System and method of taking and collecting tissue cores for treatment

ABSTRACT

A tissue cutting device that is especially suited for neurosurgical applications is disclosed and described, as well as alternative systems for tissue preservation and transport. The cutting device includes an outer cannula in which a reciprocating inner cannula is disposed. A tissue collector is also provided and is in fluid communication with the lumen of the inner cannula. A temperature control sleeve may be disposed around the tissue collector to control the temperature of the tissue samples. A preservation system may be supplied that is configured to deliver fluids to tissue samples in the tissue collector. A fluid supply sleeve may be disposed about the outer cannula and is selectively positionable along the length of the outer cannula.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/102,283 filed Aug. 13, 2018, which is a continuation of U.S.application Ser. No. 14/513,639, filed Oct. 14, 2014, now U.S. Pat. No.10,048,176 issued Aug. 14, 2018, which is a divisional application ofU.S. application Ser. No. 13/352,069 filed Jan. 17, 2012, now U.S. Pat.No. 9,279,751 issued Mar. 8, 2016, which is continuation-in-part of U.S.application Ser. No. 12/475,258, filed May 29, 2009, now U.S. Pat. No.9,216,031 issued Dec. 22, 2015, which is a continuation-in-part of U.S.application Ser. No. 12/435,724, filed on May 5, 2009, now U.S. Pat. No.8,460,327 issued on Jun. 11, 2013, which is a continuation-in-part ofU.S. application Ser. No. 12/404,407, filed on Mar. 16, 2009, now U.S.Pat. No. 8,496,599 issued on Jul. 30, 2013, which is acontinuation-in-part of U.S. application Ser. No. 12/391,579, filed onFeb. 24, 2009, now U.S. Pat. No. 8,702,738 issued on Apr. 22, 2014,which is a continuation-in-part of U.S. application Ser. No. 12/389,447,filed on Feb. 20, 2009, now U.S. Pat. No. 9,655,639 issued May 23, 2017,which is a continuation-in-part of U.S. application Ser. No. 12/336,054,filed Dec. 16, 2008, now U.S. Pat. No. 8,430,825 issued on Apr. 30,2013, and U.S. application Ser. No. 12/336,086, filed Dec. 16, 2008, nowU.S. Pat. No. 8,657,841 issued on Feb. 25, 2014, each of which is herebyincorporated by reference in its entirety.

TECHNICAL FIELD

The present disclosure relates to a system and method for resecting andcapturing the resected tissue, while maintaining that tissue within asterile surgical environment so that the resected tissue may be utilizedin the creation of targeted, patient specific treatment purposes, suchas personalized medicine.

BACKGROUND

Various abnormalities of body's bodily systems, including theneurological system, can cause severe health risks to patients afflictedby them. For example, in connection with a neurological system,abnormalities such as brain and spinal tumors, cysts, lesions, or neuralhematomas can lead to deterioration in motor skills, nausea or vomiting,memory or communication problems, behavioral changes, headaches, orseizures. In certain cases, resection of abnormal tissue masses isrequired. However, given the various complexity and importance ofvarious bodily functions where the abnormality may be found, suchprocedures may be extremely delicate and must be executed with greatprecision and care.

Various tissue removal systems are known or have been proposed forexcising abnormal tissue from healthy tissue. However, many known tissuecutting devices suffer from an inability to precisely and atraumaticallyremove neurological tissue without causing damage to the tissue to beremoved, as well as to the surrounding tissues which tissues to beremoved are connected or attached to. This “traction” or pull on thesurrounding collateral tissue and structures can cause unintendeddamages to the surrounding tissue. Additionally, various other tissueremoval systems use ablative, disruptive or thermal energy, or acombination of these, which cause damage to the excised tissues, as wellas the substrate and collateral tissue healthy tissues. Further, someprior art devices also do not provide for successive excision of tissuesamples without removal of each tissue sample between each resectioncycle.

Damage to the surrounding tissue can also damage the substrate fromwhich the diseased tissue is excised which is also the “receptor bed”for the delivery and uptake by in-situ tissues for personalized medicineregimens. In addition, many known devices are not configured to both“debulk” large volumes of tissue rapidly near clinically importantstructures or tissues, as well as be able to finely shave on a cellularlayer by layer allowing for control, on or around, more delicatestructures, such as vessels, nerves, and healthy tissue. Therefore, theprior art devices lack the flexibility as one instrument, which isrequired in most neurological procedures. Indeed, many prior art devicessimply provide for a ripping or tearing action that removes diseasedtissue away from the patient. While some prior art instruments arecapable of tissue removal via shaving, these instruments are powered byablative energy sources. Accordingly, these tissue removal mechanismsare not suitable for use when the integrity and viability of the tissueis desired to be maintained for subsequent use for the formulation ofpersonalized medicine regimens. Nor do they allow for the capture andpreservation of the resected tissue within a sterile environment.Additionally, the ablative energy that these devices generate alsoeffects the collateral tissue, such as the substrate from which thetumor has been resected which causes the substrate to be damaged andless or even non-effective as a “receptor bed” for subsequent in-situpersonalized medicine regimens.

Once diseased tissue is removed, traditionally patients are treated witha “one-size” fits all approach which typically includes a generic andheavy chemotherapy protocol regimen which is delivered to the entirebody and designed to provide a balance between enough poison to kill thecancerous tissue without killing all of the healthy tissue. High dosesand multiple exposures to radiation are also typically used anddelivered by products such as the Gamma Knife and Cyber Knife. However,such invasive treatment regimens are often nothing more than a series of“experiments” on the patient in an effort to find an effective treatmentplan. Accordingly the patient must be monitored to ascertain theeffectiveness of the generic therapeutic regimen and continuousmodification and tweaking of the treatment regime is performed basedupon the positive or negative results of each of the previous successesor failures while attempting to balance the sparing of healthy tissuesand poisoning effect of the treatment process on the whole patient. Sucha treatment regime effectively results in the patient being a guinea piguntil an effective treatment regime is achieved to manage the disease orin most cases the patient dies from the disease. Unfortunately, in thecase of brain cancers, the patient often succumbs to the disease beforean effective treatment regime is achieved. Regardless of these heroicclinical efforts that are very biologically caustic to the patient,rarely are any of the current treatment paradigm curative. In fact,since patients diagnosed with brain cancers often do not typically livebeyond 9-14 months after initial diagnosis of the disease, long termclinical implications of whole body chemo or target directed radiationtherapy are unknown in these patients and may be detrimental if thepatient lived long enough for the true impact to be understood.

However, currently evolving treatment protocols for certain diseasescalls for patient specific targeted therapies, i.e., personalizedmedicine. Several forms of personalized medicine utilize diseased tissuefrom the patient, i.e., excised tissue, to obtain information about thegeneral disease type, as well as the specific genetic and molecularmake-up of the patient's specific disease. From this information, atargeted or personalized oncological treatment regime may be developedthat requires the use of the patient's own tissue, which is cultured andused to create a patient specific “cocktail” which may then be deliveredback into the patient as a tailored specific therapy regime for thatpatient.

For effective treatment protocols to be developed, the tissue resectedfrom the patient must be removed, collected and transported in a waythat does not compromise the biological integrity or efficacy of thetissue so that it may be not only analyzed by pathology but so furtheroncological processing may be performed on the tissue so that a patientspecific therapeutic cocktail may be created. Traditionally,pathologists only receive limited quality tissue samples and/or limitedamounts of tissue due to tissue being damaged during the removalprocess, or that only a small amount of tissue was able to be retrieved.Tissues for pathological evaluation usage are not required to bemaintained in a sterile or aseptic format once removed from within asterile field, nor was biological integrity or efficacy required. Theonly requirements were that the tissue not be crushed beyond recognitionand not dehydrated. However, for certain types of personalized medicinesto be effectively created, there must be sufficient tissue harvestedfrom the tumor and available to an oncological lab (vs. a pathologylab), it must be biologically active and intact, while maintained in asterile or aseptic environment so that it is not contaminated by foreignmatter or biological elements such as bacteria, fungus, etc. Thisuncompromised environment allows for the effective subsequent culturingof tissue thus allowing the creation of a specific patient therapeuticregimen that enables the creation of personalized medicine therapies.More specifically, there must be an adequate volume of tissue harvestedfrom the tumor, maintained in a sterile or aseptic environment thatallows for the resected tissue to be divided for further use as tissuethat may be effectively cultured. In some cases it is preferable thatthe resected tissue be presented to pathology or for oncologicalprocessing in predefined consistent sized samples. This offers theopportunity for less manual handling at the point of lab processing ofthe tissue and therefore less inadvertent physical to the tissuearchitecture damage which further impacts the true yield of tissueavailable for pathological or oncological use. Another benefit is thatit provides pathology more discreet units for evaluation rather than anen-bloc presentation to pathology (where the en-bloc tissue may only bedivided up a few times) of tissue thereby enabling a more completeevaluation of more samples which may produce a more effective evaluationfrom more of the tumor material. In the case of oncological processingfor the creation of patient specific chemotherapy, the tissue samplesare first analyzed by pathological means for the determination ofspecific types of tumor information. Once determined, the tissue, whichhas been maintained in a sterile or aseptic environment, is then platedfor culturing and a variety of different “chemical cocktails” of varyingdegrees of intensity and composition may be applied to determine which“cocktail” provides the most effective “kill” to the cancer and theleast amount of damage to healthy tissue. This procedure is typicallyreferred to as “targeted chemotherapy.” An example of the screening ofsuch candidate therapeutic or chemotherapeutic agents for efficacy as toa specific patient is described in U.S. Pat. No. 7,678,552, which isassigned to Precision Therapeutics, Inc. (Pittsburgh, Pa.), the contentsof which are incorporated herein by reference in its entirety.

Another emerging therapy that has been developed is immunotherapytreatments. Immunotherapy treatments utilize the immune system of thepatient to fight disease. Generally, such treatments involve harvestingantigen presenting tissue and/or cells from the patient and incubatingthe tissue/cells containing the antigen of the specific diseased beingtargeted. The antigen presenting cells swallow up the disease antigenand present the antigen on its surface. The antigen presenting cells arethen placed in-situ back into the patient to boost and/or function totrain the body's own T-cells to attack any cells that display thedisease antigen. Additionally, there are other forms of treatmentregimes that use the patient's own tumor cells and tissues, which havebeen cultured to create specific cocktails to be delivered in-situ whichare viral based vectors. An example of one company employing such atechnique is Tocagen, Inc. (San Diego, Calif.).

The current challenge for prior art tissue cutting devices is theability to achieve a safe and effective Gross Total Resection (GTR) ornear GTR, to provide the lab with intact segments (biopsy qualitytissue, not just cells or macerated tissue) of patient's tissue withlittle to no crush artifact. Consistency in the “bite” size of theresected tissue is also a challenge. Same or near same sizeddimensionally resected tissue bites would minimize post processinghandling for oncological use and culturing. A slurry of cells ormacerated tissue is not very useful for pathology and unacceptable foran effective oncologically based treatment protocol when tissueculturing is required, current resection techniques and devices do noteffectively deliver what is required.

The tissue resected by the surgeon and analyzed by the pathologist isthe source of crucial information and that same tissue is used to createfrom the patient's own tissues the appropriately effective treatmentprotocol to be used. Indeed, the surgically resected tissue possessesthe molecular information needed to define the specific molecularcharacteristics of the patient's tumor, the specific therapies to whichthe tumor would be expected to respond, and even the specific risks ofadverse reactions to given therapies predicted by the patient's geneticmake-up.

However, safeguarding the molecular integrity and efficacy of theresected tissue while in the operating room and during transport to thelaboratory, is currently a challenge. Tissue samples react tophysiological stress. For example, once successfully resected, thespecimen may spend varying amounts of time in a biologically unfriendlyenvironment such as at room temperature in the surgical suite and/orholding unit, allowed to be exposed to atmosphere, allowed to dry out,placed in a non-sterile/non-aseptic environment, etc. before beingdelivered to the laboratory. Temperature may alter the molecularcomposition and quality of the tissue samples. Similarly, otherphysiological stress may also detrimentally impact the tissue samples,such as perfusion and oxygenation.

Immunotherapy treatments require biologically active tissue that aretissue blocks, not just individual cells. In fact, it is known thatindividual cells from diseased tissue respond and act biologicallydifferently than do “colonies” (blocks) of tissue when subjected orexposed to therapeutic agents. Thus tissue must be resected withoutcrush artifact, ablative destruction of the cell walls or thermaldamage, such as char, for the benefit of pathological evaluation and foruse in personalized medicine oncological therapies. Additionally, it isnot just the viability of the resected tissue that must be consideredbut also the substrate from which the resected tissue has been harvestedthat also must be respected and not damaged so that it may act as aneffective receptor bed for personalized medicine therapeutic regimensthat require in-situ placement of the regimen. Moreover, these treatmentregimens also require a minimum volume of tissue for effective use.Finally, the tissue that is resected, collected, transported, must bepreserved in an aseptic or preferably a sterile environment whichprecludes dehydration, contamination or compromise so it may remainbiologically active and efficacious so that it may be cultured (i.e.,living and biologically active tissue that is not compromised withcontamination) for additional/advanced pathology based tissue testingand the needs of further processing to accomplish the needs ofneuro-oncology and neuro-immunology for targeted therapies such aschemo, viral and other immune therapies for the achievement ofpersonalized medicine.

Thus, a need has arisen for a system that utilizes a tissue cuttingdevice that addresses the foregoing issues, as well as a system thatprovides for effective transport of resected tissue while minimizing, ifnot eliminating detrimental stress on the tissue samples.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the present disclosure will now be described by way ofexample in greater detail with reference to the attached figures, inwhich:

FIG. 1 is a perspective view of a tissue cutting device including afluid supply sleeve in accordance with a first embodiment;

FIG. 2 is a cross-sectional view of the tissue cutting device of FIG. 1depicting an inner cannula in a first relative position with respect toan outer cannula in which the inner cannula's distal end is locatedproximally of the outer cannula's distal end;

FIG. 3 is a cross-sectional view of the tissue cutting device of FIG. 1depicting the inner cannula in a second relative position with respectto the outer cannula in which the inner cannula's distal end is locatedat the distal end of the outer cannula;

FIG. 4 is a partial cross-sectional view of the tissue cutting device ofFIG. 1 in a first configuration in which a device-mounted tissuecollector is disconnected from a tissue cutting device housing;

FIG. 5 is a partial cross-sectional view of the tissue cutting device ofFIG. 4 in a second configuration in which the device-mounted tissuecollector is connected to the tissue cutting device housing;

FIG. 6 is a partial cross-sectional view of an alternate embodiment ofthe tissue cutting device of FIG. 1 in a first configuration in whichthe device-mounted collector is disconnected from the tissue cuttingdevice;

FIG. 7 is partial cross-sectional view of the tissue cutting device ofFIG. 6 in a second configuration in which the device-mounted tissuecollector is connected to the tissue cutting device;

FIG. 8 is a broken side elevation view of the outer cannula of thetissue cutting device of FIG. 1 ;

FIG. 9 is a broken side elevation view of the inner cannula of thetissue cutting device of FIG. 1 ;

FIG. 10 is a top plan view of a portion of the outer cannula of thetissue cutting device of FIG. 1 with the inner cannula removed from theouter cannula;

FIG. 11 is a top plan view of a portion of the inner cannula of thetissue cutting device of FIG. 1 ;

FIG. 12 is a top plan view of a portion of the outer cannula and innercannula of FIG. 1 depicting the inner cannula inserted into the outercannula;

FIG. 13 is a partial cross-sectional view of a distal region of theouter cannula and the inner cannula of the tissue cutting device of FIG.1 , depicting the inner cannula in a first relative position withrespect to the outer cannula;

FIG. 14 is a partial cross-sectional view of a distal region of theouter cannula and the inner cannula of the tissue cutting device of FIG.1 , depicting the inner cannula in a second relative position withrespect to the outer cannula;

FIG. 15 is an exploded assembly view of the tissue cutting device ofFIG. 1 ;

FIG. 16 a is a side elevation view of a cam of the tissue cutting deviceof FIG. 1 ;

FIG. 16 b is an end elevation view of the cam of FIG. 16 a;

FIG. 17 a is a perspective view of a cam transfer mechanism of thetissue cutting device of FIG. 1 ;

FIG. 17 b is a perspective view of a cam follower of the tissue cuttingdevice of FIG. 1 ;

FIG. 18 is a partial perspective view of a portion of the tissue cuttingdevice of FIG. 1 with an upper shell of an outer sleeve upper housingremoved to show a dial for rotating an outer cannula;

FIG. 19 is a partial side cross-sectional view of the portion of thetissue cutting device of FIG. 18 ;

FIG. 20 is a side elevation view of an inner and outer cannula assemblyof the tissue cutting device of FIG. 1 ;

FIG. 21A is a tissue cutting system including a remote tissue collector,control console, foot pedal, and the tissue cutting device of FIG. 1 ;

FIG. 21B is an enlarged view of the remote tissue collector of FIG. 21A;

FIG. 21C is an embodiment of a part of the tissue cutting system of FIG.21A, with a tissue preservation adapter system positioned between thetissue collector and the tissue cutting device;

FIG. 21D is a partial cross-sectional view of the preservation adaptersystem of FIG. 21C;

FIG. 21E is a partial close-up view of a first connector of thepreservation adapter system of FIG. 21C;

FIG. 22 is a block diagram of a control scheme for the tissue cuttingsystem of FIG. 22 ;

FIG. 23 is diagram of the tissue cutting device of FIG. 1 and the motorcontrol unit of FIG. 22 ;

FIG. 24 is a partial cross-sectional view of the tissue cutting deviceof FIG. 1 depicting motor shaft position sensors for controlling a stopposition of an inner cannula;

FIG. 25 is a partial cross-sectional view of the outer cannula and innercannula of the tissue cutting device of FIG. 1 with the inner cannula ina first position relative to the outer cannula;

FIG. 26 is a partial cross-sectional view of the outer cannula and innercannula of the tissue cutting device of FIG. 1 with the inner cannula ina second position relative to the outer cannula;

FIG. 27 is a partial cross-sectional view of the outer cannula and theinner cannula of the tissue cutting device of FIG. 1 with the innercannula in a third position relative to the outer cannula; and

FIG. 28 is a side elevational view of the fluid supply sleeve of FIG. 1;

FIG. 29 is a partial close-up, longitudinal cross-sectional view of thefluid supply sleeve, outer cannula and inner cannula of FIG. 1 ;

FIG. 30 is a transverse cross-sectional view taken along line 30-30 inFIG. 29 ;

FIG. 31 is a close-up, partial side elevational view of the fluid supplysleeve of FIG. 1 selectively disposed along the length of the outercannula of FIG. 1 ; and

FIG. 32 is a close-up, partial top plan view of the fluid supply sleeveof FIG. 1 selectively disposed over a portion of the outer cannulaopening of FIG. 1 .

FIG. 33A is a partial cross-sectional view of a tissue collector with achilling sleeve.

FIG. 33B is a partial cross-sectional view of a tissue collector with anormally closed cap member.

FIG. 33C is an end view of the normally closed cap member of FIG. 33B.

FIG. 33D is an enlarged view of an embodiment of the normally closed capmember of FIG. 33B.

FIG. 34 is an exploded view of a cooling system for use with a tissuecollector.

FIG. 35 is a perspective view of the cooling system of FIG. 34 with thetissue collector positioned therein.

FIG. 36 is a partial exploded perspective view looking into the coolingsystem of FIG. 34 .

FIG. 37 is a partial exploded perspective view looking at the bottomsurface of an exemplary lid that may be used with the cooling system ofFIG. 34 .

DETAILED DESCRIPTION

Referring now to the discussion that follows and also to the drawings,illustrative approaches to the disclosed systems and methods are shownin detail. Although the drawings represent some possible approaches, thedrawings are not necessarily to scale and certain features may beexaggerated, removed, or partially sectioned to better illustrate andexplain the present disclosure. Further, the descriptions set forthherein are not intended to be exhaustive or otherwise limit or restrictthe claims to the precise forms and configurations shown in the drawingsand disclosed in the following detailed description.

Described herein are tissue cutting devices that are suited for surgicalapplications. While described herein in connection with neurosurgicalapplications such as the removal of spine and brain tissue, it isunderstood that the disclosure herein is applicable to other surgicalapplications and treatment protocols. As described herein, the devicesmay be configured with a fluid supply sleeve that may be selectivelydisposed on an outer cannula and selectively positionable along thelength of the outer cannula. As a result, the fluid supply sleeve can beconfigured to supply fluids such as irrigants, hemostatic agents,pharmacological therapeutics and/or tissue sealants to a surgical site,and adjacent a tissue cutting opening of the surgical device 40. Theycan also be used to selectively adjust the area of the outer cannulaaperture through which the aspiration is delivered through to thetissue.

Methods and system for preserving tissue samples for use in developmentof personalized medicine regimens are also disclosed. The systemsdisclosed herein permit transport of excised tissue samples, whileprotecting the tissue samples from, for example, adverse environmentalstress.

Referring to FIG. 1 , a tissue cutting device 40 includes a handpiece 42and an outer cannula 44. In one exemplary embodiment, handpiece 42 isgenerally cylindrical in shape and is preferably sized and shaped to begrasped with a single hand. Handpiece 42 includes a lower housing 50which comprises a proximal section 46 and distal section 48. Lowerhousing 50 comprises a proximal-most housing portion 82 (FIGS. 2 and 3 )that is connected to a motor housing 71, and a cam housing 69 that isconnected to motor housing 71. A front housing section 51 is connectedto cam housing 69. Upper housing 52 is also provided. A tissue collector58 may be operatively connected to upper housing 52 (as will beexplained in further detail below). A rotation dial 60 for rotating theouter cannula 44 with respect to handpiece 42 is also mounted to upperhousing 52.

As best seen in FIGS. 2, 3, and 20 , outer cannula 44 includes an openproximal end 45, a closed distal end 47, and a distal opening 49proximate distal end 47. Tissue cutting device 40 further comprises aninner cannula 76 which is partially disposed in an outer cannula lumen110 (FIG. 8 ). Inner cannula 76 is configured to reciprocate withinouter cannula lumen 110 and to cut tissue samples entering outer cannula44 via outer cannula distal opening 49, without crush artifact orthermal damage, as will be described in greater detail below. Innercannula 76 reciprocates between a proximal position, which is depictedin FIG. 2 and a distal position which is depicted in FIG. 3 . Innercannula 76 includes an open proximal end 77 and an open distal end 79.Distal end 79 is configured to cut tissue, and in exemplary embodimentsis capable of cutting neurological system tissues such as those from thebrain or spine. In one exemplary embodiment, inner cannula distal end 79is beveled in a radially inward direction to create a sharp circular tipand facilitate tissue cutting.

Outer cannula 44 is not translatable with respect to handpiece 42 suchthat its position with respect to handpiece 42 along the direction ofthe longitudinal axis of handpiece 42 remains fixed. An exemplary fluidsupply sleeve 302 (FIG. 1 ) may be selectively attachable to outercannula 44. Fluid supply sleeve 302 is configured to allow fluids to beprovided proximate a surgical site and/or adjacent distal opening 49. Inone exemplary configuration, fluid supply sleeve 302 has a proximal hub306 and a distal end 320. An outer cannula opening 322 is provided atthe proximal end of fluid supply sleeve 302. An elongated channelsection 304 is connected to proximal hub 306 and projects distally awayfrom it. Distal end 320 of fluid supply sleeve 302 is the distal end ofthe elongated channel section 304. In FIG. 1 , fluid supply sleeve 302is shown in an installed condition on outer cannula 44. In the depictedinstalled condition, fluid supply sleeve 302 is selectively positionablealong the length of outer cannula 44.

In FIGS. 2-3 , fluid supply sleeve 302 is not shown for ease of viewing.Motor 62 is disposed in proximal lower housing section 46 of handpiece42 and is operably connected to inner cannula 76 to drive thereciprocation of inner cannula 76 within outer cannula lumen 110. Motor62 may be a reciprocating or rotary motor. In addition, it may beelectric or hydraulic. However, in the embodiment of FIGS. 2 and 3 ,motor 62 is a rotary motor, the rotation of which causes inner cannula76 to reciprocate within outer cannula lumen 110.

Motor 62 is housed in motor housing 71, which defines a portion of lowerhousing proximal section 46. Motor 62 is connected to an inner cannuladrive assembly 63 which is used to convert the rotational motion ofmotor 62 into the translational motion of inner cannula 76. At itsproximal end, motor housing 71 is connected to proximal-most housingportion 82, which includes a power cable port 84 and a hose connector43, which in the exemplary embodiment of FIG. 3 is configured as aneyelet. However, it is understood that hose connected 43 may embodyother configurations. Hose connector 43 provides a mechanism forsecurely retaining a vacuum system hose to handpiece 42, therebyallowing vacuum to be supplied to tissue collector 58.

Inner cannula driver assembly 63 (not separately shown in figures)comprises a cam 64, a cam follower 68, a cam transfer 72, and a cannulatransfer 74. Cam 64 is a generally cylindrical structure and is shown indetail in FIGS. 16A and 16B. A groove or channel 65 is defined in thesurface of cam 64. In one exemplary embodiment, groove 65 is continuousand circumscribes the perimeter of cam 64 but is not orientedperpendicularly to the longitudinal axis of cam 64, i.e., groove 65 isangled with respect to the cam axis. Opposing points on groove 65 suchas points 65 a and 65 b (FIGS. 2 and 3 ) define pairs of “apexes” thatare spaced apart along the longitudinal axis of the cam, i.e., thegroove extends along a portion of the length of the cam. Cam 64 alsoincludes a proximal opening 114 (FIG. 16 a ) for receiving a motor shaftand a proximal recess 116 into which a shaft may be snugly received.Holes 118 and 120 are provided for mounting position indicators thatcooperate with a position sensor to determine the angular position ofcam 64, and correspondingly, the linear position of inner cannula 76within the outer cannula lumen 110, as discussed below.

Cam follower 68 is depicted in detail in FIG. 17B. Cam follower 68 is agenerally rectangular block shaped structure with a hollow interior inwhich cam 64 is partially disposed. Cam follower 68 also includes a hole70 in its upper face in which a ball bearing (not shown) is seated. Theball bearing rides in cam groove 65 and engages cam transfer 72. As aresult, when cam 64 rotates, cam follower 68 translates along the lengthof handpiece 42. Cam follower 68 also includes lateral slots 182 a and182 b that cooperatively engage corresponding members 178 a, 178 b fromcam transfer 72.

Cam follower 68 is disposed within a cam chamber 67 formed in camhousing 69. Cam 64 is partially disposed in cam chamber 67 and extendsproximally therefrom to engage motor 62. Cam housing 69 comprises partof distal portion 48 of handpiece 42. Cam 64 does not reciprocate withincam chamber 67 and instead merely rotates about its own longitudinalaxis. However, cam follower 68 reciprocates within cam chamber 67 alongthe direction of the length of handpiece 42. Cam follower 68 is open atits proximal end to receive cam 64. As shown in FIGS. 15 and 16A, cam 64may optionally include a threaded distal end 123 that projects through adistal opening 191 (FIG. 17 b ) in cam follower 68 and which engages anut 190 (FIG. 15 ) to prevent reciprocation of cam 64 relative to camhousing 69. Proximal cam bearing 186 and distal cam bearing 188 (FIG. 15) may also be provided to support cam 64 as it rotates within camhousing 69.

Cam transfer 72 extends from cam chamber 67 into a cam transfer chamber73 formed in upper housing 52. As best seen in FIG. 17 a , cam transfer72 comprises a proximal end 72 a that is attachable to cam follower 68and a distal end 72 b that is attachable to inner cannula 76 via cannulatransfer 74. Proximal end 72 a comprises a pair of spaced apart,downwardly extending members 178 a and 178 b, and distal end 72 bcomprises a pair of spaced apart upwardly extending members 180 a and180 b. Downwardly extending members 178 a and 178 b are spaced apart ina direction that is perpendicular to the length of cam 64 and handpiece42, while upwardly extending members 180 a and 180 b are spaced apart ina direction that is parallel to the length of cam 64 and handpiece 42.Cam follower slots 182 a and 182 b engage downwardly extending members178 a and 178 b of cam transfer 72. Downwardly extending members 178 aand 178 b of cam transfer 72 may be resilient and may have engagementportions 179 a and 179 b on their free ends (e.g., hooks or clips) forsecurely engaging the bottom and side surfaces of cam follower 68.

As best seen in FIG. 20 , cannula transfer 74 comprises a sleevedisposed about inner cannula 76. For ease of viewing, fluid supplysleeve 302 is not shown in FIG. 20 . Cannula transfer 74 comprises aproximal end 128, middle section 127, and distal end 126. Upwardlyextending members 180 a and 180 b of cam transfer 72 define fork-shapedstructures that receive and cradle middle section 127 of cannulatransfer 74. Distal end 126 and proximal end 128 of cannula transfer 74are disposed outwardly of upwardly extending members 180 a and 180 b andare shaped to prevent relative translation between cam transfer 72 andcannula transfer 74. In the depicted embodiments, distal end 126 andproximal end 128 of cannula transfer 74 are enlarged relative to middlesection 127 to abut the upwardly extending, fork-shaped members 182 aand 182 b, thereby preventing relative translation between cam transfer72 and cannula transfer 74. As a result, when cam transfer 72reciprocates along the length of handpiece 42, cannula transfer 74reciprocates as well. Because it is affixed to inner cannula 76, whencannula transfer 74 reciprocates, it causes inner cannula 76 toreciprocate within outer cannula 44.

In one exemplary arrangement, motor 62 is a brushed DC motor and may beoperably connected to cam 64 in a number of ways. In the embodiment ofFIGS. 2 and 3 , motor 62 includes a distally extending shaft 66 thatextends into a proximal opening 114 and engages recess 116 (FIGS. 16Aand B) defined in cam 64. Shaft 66 may be connected to cam 64 via athreaded connection, adhesive, or other known connection means. In analternate implementation, depicted in FIG. 15 , a separate cam coupler184 is provided. Cam coupler 184 is seated in proximal opening 114 andhas a width greater than the diameter of opening 114. Cam coupler 184 isalso connected to motor shaft 66 such that rotation of shaft 66 causescam coupler 184 to rotate, which in turn causes cam 64 to rotatetherewith. One revolution of motor shaft 66 causes cam 64 to rotate byone revolution, which in turn causes inner cannula 76 to reciprocate byone complete stroke, i.e., from the position of FIG. 2 to the positionof FIG. 3 and back to the position of FIG. 2 .

Cam transfer 72 may be connected to cam follower 68 by mechanical means,adhesive means or other known connection means. In one exemplaryembodiment, downwardly extending members 178 a and 178 b mechanicallyclip onto and removably engage cam follower 68. In another embodiment,cam transfer 72 is adhesively affixed to cam follower 68. In yet anotherembodiment, both mechanical and adhesive connections are used. The ballbearing (not shown) disposed in cam follower hole 70 traverses camgroove 65 as cam 64 rotates, causing cam follower 68 to reciprocate fromthe proximal position of FIG. 2 to the distal position of FIG. 3 . As aresult, cam transfer 72, cannula transfer 74 and inner cannula 76translate between their respective proximal positions of FIG. 2 andtheir respective distal positions of FIG. 3 when motor 62 and cam 64rotate.

Motor 62 is preferably selected to have a rotational speed that allowsinner cannula 76 to reciprocate from the position of FIG. 2 to theposition of FIG. 3 and back to the position of FIG. 2 at a rate of atleast about 1,000 reciprocations/minute. Reciprocation rates of at leastabout 1,200 reciprocations/minute are more preferred, and reciprocationrates of at least about 1,500 reciprocations/minute are even morepreferred. Reciprocation rates of less than about 2,500reciprocations/minute are preferred. Reciprocation rates of less thanabout 2,000 are more preferred, and reciprocation rates of less thanabout 1,800 reciprocations/minute are even more preferred. As best seenin FIG. 14 , the rates of reciprocation of device 40 allow tissue to besevered into “snippets” 112 which are relatively smaller than “slug”tissue samples obtained by many prior devices. The smaller sized“snippet” 112 format permits use of the excised tissue samples forpathology or diagnostic purposes without necessarily requiring furthermanual or mechanical reduction of sample sizes. The smaller size samplesprovides a benefit as handling of tissue samples to reduce the size ofexcised tissue samples may expose the tissue to environmental factorsthat may degrade or otherwise compromise the biological integrity of thetissue samples. For example, in reducing the size of the excised tissuesamples, bacteria may be inadvertently introduced. In the exemplaryconfiguration shown, as the reciprocation of the tissue cutting devicecontinues, a continuum of severed tissue snippets 112 is obtained.

As mentioned previously, outer cannula 44 includes an opening 49 forreceiving tissue into outer cannula lumen 110. As best seen in FIGS.8-12 , opening 49 is preferably defined by a cutting edge 51 that isconfigured to sever tissue and a non-cutting edge 53 that is notconfigured to sever tissue. In certain exemplary implementations,cutting edge 53 has a radial depth “d” that is no greater than about 50%of the outer diameter of outer cannula 44. In one exemplaryimplementation, cutting edge 51 is beveled in a radially inwarddirection, non-cutting edge 53 is not beveled, and cutting edge 51 islocated immediately distally of non-cutting edge 53. Inner cannuladistal end 79 is preferably configured to cut tissue. In one exemplaryembodiment, distal end 79 is beveled in a radially inward directionaround the circumference of inner cannula 76 to provide a sharp edge. Astissue is received in outer cannula opening 49, it is compressed betweeninner cannula distal end 79 and outer cannula cutting edge 51, causingthe received tissue to be cleanly severed from the surrounding tissue,without crush artifact or thermal damage to the tissue.

Tissue cutting device 40 is particularly well suited for use in cuttingtough tissues such as spinal and brain tissues. Outer cannula 44 andinner cannula 76 comprise materials that are generally rigid, such asrigid plastics or metal. In one preferred implementation, both cannulaecomprise stainless steel, and more preferably, 304SS typically used inmedical grade instruments.

As best seen in FIGS. 9-14 , to facilitate the cutting of tough tissues,inner cannula 76 includes a hinge 80. For ease of viewing, fluid supplysleeve 302 is not shown in FIGS. 9-14 . Hinge 80 is located betweeninner cannula body section 81 which is located on the proximal side ofhinge 80 and inner cannula cutting section 83 which is located on thedistal side of hinge 80. In one exemplary arrangement, hinge 80 is aliving hinge. As used herein, the term “living hinge” refers to a thin,flexible hinge that joins two relatively more rigid parts together. Inone example, hinge 80 is a living hinge that is integrally formed withinner cannula body section 81 and inner cannula cutting section 83 byremoving a portion of the circumference of the inner cannula 76 along alength L (FIG. 11 ). Hinge 80 allows cutting section 83 to pivot abouthinge 80 as inner cannula 76 reciprocates within outer cannula 44. Asinner cannula 76 translates in the distal direction, it contacts tissuereceived in outer cannula opening 49 and encounters progressivelyincreasing resistance from the tissue as the tissue is urged in thedistal direction. As the resisting force of the tissue increases,cutting section 83 pivots progressively more until a zero annularclearance is obtained between inner cannula distal end 79 and outercannula opening 49. The received tissue is severed and aspirated in theproximal direction along inner cannula lumen 78 and received in tissuecollector 58. Thus, inner cannula lumen 78 provides an aspiration pathfrom the inner cannula distal end 79 to the inner cannula proximal end77. Hinge 80 allows a generally zero annular clearance to be obtainedbetween inner cannula distal end 79 and outer cannula opening 49 atcutting section 83 while not affecting the annular clearance betweeninner cannula body section 81 and outer cannula 44. This configurationmaximizes tissue cutting while minimizing frictional losses that wouldotherwise occur due to the frictional engagement of the outer surface ofinner cannula body section 81 and the inner surface of outer cannula 44if a very small annular clearance between the outer cannula 44 and innercannula 76 were present.

Outer cannula opening 49 may have a number of shapes. In certainexamples, when outer cannula opening 49 is viewed in plan, it has ashape that is generally square, rectangular, trapezoidal, ovular, or inthe shape of the letter “D.” In certain other exemplary implementations,outer cannula opening 49 is configured to direct tissue so that it maybe compressed as inner cannula 76 translates in the distal direction. Inone exemplary embodiment, depicted in FIGS. 10 and 12 , outer cannulaopening 49 has a generally triangular shape when outer cannula opening49 is viewed in plan. As FIGS. 10 and 12 indicate, when viewed in plan,the width of opening 49 in a direction transverse to the outer cannulalongitudinal axis varies longitudinally along the length of outercannula 44, and preferably narrows from the proximal to distal portionsof opening 49. When viewed in side elevation, cutting edge 51 slopes ina radially outward direction moving distally along edge 51. As a result,as a tissue sample is distally urged within outer cannula opening 49 bythe action of inner cannula 76, the tissue is increasingly compressed inthe direction of the circumference of inner cannula 76 (or in thedirection of the “width” of opening 49 when viewed in plan). To ensurecomplete cutting, inner cannula distal end 79 preferably travels to aposition that is distal of outer cannula opening 49 during a tissuecutting operation, i.e., there is an inner cannula overstroke.

As mentioned above, tissue cutting device 40 aspirates tissue samplesreceived in inner cannula lumen 78 to cause the tissue samples to movein the proximal direction along the length of the inner cannula 76. Inembodiments wherein tissue collection is desired, device 40 preferablyincludes a tissue collector 58 into which aspirated tissue samples aredeposited during a tissue cutting procedure. Tissue collector 58 may belocated remotely from handpiece 42 and outside the sterile field duringa tissue cutting operation as shown in FIG. 21A. However, in certainembodiments, as best seen in the examples of FIGS. 1-7 , tissuecollector 58 is removably connected directly to handpiece 42 within thesterile field. However, it is understood that tissue collector 58 mayalso be remotely connected to handpiece 42, while in the sterile field,as well. In either embodiment, a fluid collection canister 192 may belocated between tissue collector 58 and a source of vacuum (such asvacuum generator 153 in FIG. 21A) to protect the vacuum generatingapparatus from becoming contaminated or damaged by aspirated fluids.

In other embodiments, a tissue collector may be omitted and fluidcollection canister 192 may be provided to collect both aspirated fluidand tissue. Further, fluid collection canister 192 may also be providedwith a tissue preservation solution configured to maintain the tissuesamples viability and biological integrity, such as, for example, anutrient rich solution designed to maintain the tissue samples in anaseptic environment.

Referring to FIGS. 4-7 , tissue collector 58 is connected to upperhousing 52 proximally of the inner cannula 76 to receive the aspiratedtissue samples. Tissue collector 58 is a generally cylindrical, hollowbody with an interior volume that is in fluid communication with theinner cannula lumen 78 and a source of vacuum (not shown in FIGS. 4-7 ).Tissue collector 58 may be removably secured to housing connector 96 toallow for the periodic removal of collected tissue samples, includingwhile in the sterile field. Tissue collector 58 is preferably secured toupper housing 52 in a manner that provides a substantially leak-proofvacuum seal to maintain consistent aspiration of severed tissue samples.A vacuum hose fitting 59 is formed on the proximal end of tissuecollector 58 and is in fluid communication with the interior of tissuecollector 58 and with a vacuum generator, as will be discussed below.

To enable the severed tissue samples to be used for personalizedmedicine regimens, viability and integrity of the tissue samples must bemaintained after removal of the tissue samples from the patient, andduring the collection and transport of the tissue samples to theoncological laboratory. More specifically, the tissue samples must bekept biologically active and intact, while maintained in a sterile oraseptic environment to permit the tissue to be cultured. Further,physiologic stress on the tissue samples must be minimized so as not toadversely impact the samples.

Referring to FIG. 33A, to assist in maintaining the viability andintegrity of the tissue samples, in one exemplary arrangement, tissuecollector 58 is provided with a cooling sleeve 400 that surrounds aportion of an outer surface of tissue collector 58. Cooling sleeve 400is configured to keep tissue collector 58 at a predetermined cooltemperature range which is sufficient to maintain viability of thetissue samples captured within tissue collector 58 and at least combatphysiological stress and degradation of the tissue samples due totemperature. In one exemplary configuration, cooling sleeve 400 isconfigured with a body portion 404 that generally corresponds to theouter contour of tissue collector 58, i.e., generally in the shape of atube. Alternatively, cooling sleeve 400 may be provided as a flexiblesheet that may be wrapped around an outer surface of tissue collector58, with suitable securing features (such as hook and loop fasteners)being utilized to secure cooling sleeve to tissue collector 58. Ineither arrangement, body portion 404 is sized to receive tissuecollector 58 therein and extends about at least a great portion of thelength of tissue filter 58. An optional substantially closed end face402 may be provided that further includes an opening 406 that isconfigured to permit vacuum hose fitting 59 to exit cooling sleeve 400.However, it is understood that because tissue collector 58 maintains asterile/aseptic environment for the tissue contents inside tissuecollector 58, cooling is not necessarily required to be provided as asterile component of the system. This configuration thus allows forflexibility in the applicability and ease of use of the cooling sleeve.

In one exemplary configuration, cooling sleeve 400 may includeelectrically powered cooling elements (not shown), that are operativelyconnected to a power source. When activated, cooling sleeve 400 keepstissue samples captured within tissue collector 58 at a stable,preselected temperature during collection, while cooling sleeve 400 isoperatively positioned around tissue collector 58.

In another exemplary configuration, cooling sleeve 400 may be configuredsimilar to an ice pack, in that the sleeve is configured with water,refrigerant gel or liquid sealed within between the layers of thematerial. In this arrangement, cooling sleeve 400 may be simply storedin a freezer until a surgical procedure and then positioned on tissuecollector 58. Further, because there is no need for an electrical powersource, cooling sleeve 400 may be used to control temperature duringcollection and through transport to the oncological lab. To maintain theproper shape for cooling sleeve 400, a shaper that generally correspondsto the shape of the tissue collector may be provided that is insertedinto cooling sleeve 400, while cooling sleeve 400 is stored in afreezer.

Another exemplary embodiment of a cooling system 600 is shown in FIGS.34-37 . Cooling system 600 is utilized in those embodiments where tissuecollector 58 is remotely connected to tissue resection device 40, asshown in FIGS. 21A-C, for example. Cooling system 600 includes a basemember 602 and a lid 604. Base member 602 is configured as an insulatedmember that comprises a reservoir 606 and a tissue collector chamber608. In one exemplary arrangement, tissue collector chamber 608 isdefined by a contoured wall 610, integral with base member 602. However,it is understood that a separate sleeve member may be positioned withinbase member 602 to serve as a tissue collector chamber 608.

In one exemplary arrangement, a sleeve member 612 lines and is incontact with the outside of tissue collector chamber 608. Sleeve member612 is constructed of a thermally conductive material, as will beexplained in further detail below. The wall member that defines tissuecollector chamber 608 further comprises an opening 614 (best shown inFIG. 36 ) that is in communication with reservoir 606. As will beexplained further below, opening 614 also permits sleeve member 612 todirectly contact any material that is contained within reservoir 606.

Base member 602 further comprises a narrow slit 616. Slit 616 extendsfrom a top edge 618 of base member 602 to a bottom of tissue collectorchamber 608. Slit 616 is sized to permit vacuum line 151 b to passthrough.

Lid 604 is sized to fit over base member 602 to retain materialspositioned within reservoir 606, as well as to retain tissue collector58 therein. Lid 604 further includes an opening 619 through which hosefitting 59 b extends, when tissue collector 58 is positioned withintissue collection chamber 608. In one embodiment, a bottom surface 620of lip 604 is provided with a projecting element 622 configured to fitwithin an opening of reservoir 606. A seal member (not shown) may beprovided around a peripheral edge 624 of projecting element 622 toprovide a water tight/sealed chamber. An external latching member may beprovided to secure lid 604 to base member 602.

In operation, lid 604 is removed from base member 602. Reservoir 606 isfilled with a suitable refrigerant (i.e., ice or other suitable liquid).Tissue collector 58 is positioned within tissue collector chamber 608,with vacuum line 151 b extending out of slit 616. Lid 604 is thenattached to base member 602, sealing reservoir 606. Hose fitting 59 bextends upwardly from lid 604 and is connected via vacuum line 151 a totissue resection device 40.

Due to the thermo-conductivity of sleeve 612, and because sleeve 612 isin direct communication with the refrigerant positioned within reservoir606, tissue collector 58 (and hence any tissue samples positionedtherein) are kept at a suitable temperature to maintain tissueviability. Moreover, since reservoir 606 for the refrigerant isinsulated and water tight, ice or liquid refrigerants may be directlyplaced into reservoir 606 and replenished as necessary during use.Further, in another exemplary configuration, base member 602 may beprovided with an external temperature gauge 626. Temperature gauge 626is configured to be in communication with reservoir 606 or incommunication with sleeve 612 thereby providing an indication whenadditional refrigerant may be needed and of the thermal status of thecontents within tissue collector 58. For example, in one exemplaryconfiguration an end portion of sleeve 612 is extended along a portionof base member 602. An opening (not shown) is provided through a surfaceof base member 602 and temperature gauge 626 is positioned over theopening and in contact with the extended portion of sleeve 612.Accordingly, the temperature of tissue collector 58 is communicated totemperature gauge 626.

In another exemplary arrangement, an opening (not shown) is formed inthe inside surface of base member 602, similar to opening 614.Temperature gauge 626 is positioned within base member 602 over theopening so as to be effectively in contact with reservoir 606.

Further, in addition to slit 616 providing an exit path for vacuum line151 b, slit 616 also provides an additional function. More specificallyslit 616 permits viewing of the tissue collector 58, which is preferablyconstructed of transparent or translucent material, while positionedwithin cooling system 600. With this configuration, a user will be ableto determine when tissue collector 58 is full of tissue samples.

When tissue collection is complete, vacuum line 151 b may bedisconnected from hose fitting 59 b and vacuum line 151 a may bedisconnected from tissue resection device 40, while leaving tissuecollector 58 within cooling system 600, thereby maintaining the tissuesamples in a sterile/aseptic environment, at an appropriate temperature.

To assist in removing tissue samples from tissue collector 58, in someembodiments, a selectively removable tissue filter 405 may be positionedwithin tissue collector 58. Tissue filter 405 may be configured with amesh body that retains tissue samples there within, but permits bodilyfluids to exit through the mesh body. In operation, upon completion oftissue resection, tissue collector 58 is detached from housing connector98 and tissue filter 405, holding tissue samples therein, may be removedfrom tissue collector 58. In some arrangements, tissue samples will beremoved from tissue filter 405, while in the operating room and placedin a suitable container for transport (to be explained in further detailbelow). To assist in removal of tissue samples from tissue filter 405,in one exemplary arrangement, tissue filter 405 is configured with scoop407 that is disposed within tissue filter 405. Scoop 407 includes an endportion 409 that is configured to be approximately the same size andshape as the interior of tissue filter 405. End portion 409 is securedto a pull member 410 that loops around an outer surface of tissue filter405. To remove tissue samples from filter 405, pull member 410 is pulledaway from tissue filter 405, which causes scoop 407 to advance tissuesamples to the opening of tissue filter 405. In another exemplaryconfiguration, tissue filter 405 may be configured with a hinge memberas shown and described in U.S. Pat. No. 7,556,622, the contents of whichare incorporated herein by reference.

In some instances, it may be desirable to transport tissue collector 58with tissue samples still collected therein, to the oncological lab. Forexample, to maintain the temperature of the tissue samples duringtransport, tissue collection 58, with cooling sleeve 400 still in placemay be transported to the oncological lab. However, for embodimentswhere the tissue collector 58 is directly connected to the device 40,such as that shown in FIGS. 1-7 , the distal end of tissue collector 58is typically configured to be generally open. Because it is contemplatedthat tissue collector 58 would be removed from surgical device 40 oncetissue resection is complete, in one exemplary configuration, tissuecollector 58 may be provided with a normally closed, and selectivelyremovable sterile cap member 408, shown in FIGS. 33B-33C to assist inretaining samples within tissue collector 58 during transport. In oneexemplary configuration, cap member 408 is constructed of a resilientmaterial that frictionally grips an outer edge of the distal end oftissue collector 58. A normally closed opening 412, such as a slit,serves to retain the tissue samples within tissue collector 58, whenvacuum is turned off and when tissue collector 58 is removed from device40. However, in operation, inner cannula proximal end 77 will forceopening 412 to permit tissue samples to enter into tissue collector 58.Once tissue collector 58 is transported to its destination, cap member408 may be removed from the distal end of tissue collector 58, and thetissue samples may be released. In another exemplary configuration,shown in FIG. 33D, cap member 408 is provided with an extended sleeve414 into which distal end of tissue collector 58 is received. Sleeve 414may be configured to be selectively perforated, ruptured or torn, torelease sleeve 414 from tissue collector 58. In one exemplaryarrangement, a tab member 416 may be provided to facilitate the releaseof sleeve 414 from tissue collector 58.

In the embodiment of FIGS. 4-5 , housing connector 96 is a generallycylindrical, flange extending proximally from upper housing 52. Uppershell 54 and lower shell 56 of upper housing 52 cooperatively define acavity into which a seal holder 94 is partially disposed. Seal holder 94includes a distal annular recess in which a seal 92, such as an o-ring,is disposed. Seal holder 94 also includes a central lumen through whichinner cannula 76 is slidably disposed. A proximally projecting portion95 of seal holder 94 projects away from upper housing 52 in the proximaldirection and is received within housing connector 96. As best seen inFIGS. 2 and 3 , inner cannula proximal end 77 preferably remains withinseal holder 94 as inner cannula 76 reciprocates during operation oftissue cutting device 40. However, proximal end 77 moves within sealholder 94 as inner cannula 76 reciprocates. Seal 92 preferably comprisesa resilient material such as an elastomeric material. The sealingengagement of seal 92 and inner cannula 76 prevents air or fluids fromleaking between inner cannula 76 and upper housing 52 and aids inmaintaining consistent aspiration of samples through the inner cannulalumen 78.

Housing connector 96 includes connecting features 98 and 100 which areconfigured to engage with corresponding connecting features 102 and 104on tissue collector 58. In the embodiment of FIGS. 4 and 5 , connectingfeatures 98 and 100 are “J” shaped slots formed in housing connector 96,and connecting features 102 and 104 are complementary protrusions formedon tissue collector 58 which engage connecting features 98 and 100,respectively. To connect tissue collector 58 to housing connector 96,protrusions 102 and 104 are aligned with slots 98 and 100, and tissuecollector 58 is then inserted into housing connector 96 in the distaldirection. Tissue collector 58 is then rotated to fully engageprotrusions 102 and 104 with slots 98 and 100. A seal 103 is providedaround the circumference of tissue collector 58 to sealingly engage theinner surface of housing connector 96.

An alternate embodiment of tissue collector 58 is depicted in FIGS. 6and 7 . In the embodiment of FIGS. 6 and 7 , tissue collector 58 issemi-elliptical in cross-section and includes a hollow interior forreceiving samples, as in the embodiment of FIGS. 4 and 5 . In theembodiment of FIGS. 6 and 7 , a cylindrical flange housing connector 96is not provided. Instead, upper housing 52 is formed with an engagementrecess 108 that engages a complementary clip 106 formed on tissuecollector 58. In each of the foregoing embodiments, tissue collector 58may be provided with a filter (as described above) in its interior forcollecting solid tissue samples while allowing liquids and gases (e.g.,air) to pass through. Exemplary filters include medical grade meshfilters with a mesh size smaller than that of tissue snippets 112.Further, while not specifically shown, it is understood that tissuecollector 58 shown in FIGS. 6-7 may also be provided with a coolingsleeve, as described above.

In the embodiments of FIGS. 4-7 , tissue collector 58 preferably has alongitudinal axis that is not collinear with the longitudinal axes ofhandpiece 42, motor 62, or cam 64. The longitudinal axis of tissuecollector 58 may be arranged so as to be substantially coaxial with thelongitudinal axis of inner cannula 76 to yield an “in-line” filterconfiguration. Tissue collector 58 and inner cannula 76 are both spacedapart from and substantially parallel to the longitudinal axes ofhandpiece 42, motor 62, and cam 64. Thus, the cutting axis (i.e., theouter cannula longitudinal axis) and sample aspiration path axis are notcoaxial with the longitudinal axis of the handpiece 42. As a result,when device 40 is used to cut tissue, the surgeon's view of the cuttingaxis is not obstructed by his or her hand. In addition, the surgeon cantreat the proximal end of the filter as a “gun sight” and align it witha tissue sample to be cut to thereby align the outer cannula 44 with thetissue sample, providing enhanced ergonomic benefits over previousdevices, in particular, previous neurosurgical devices. In the case of adevice with a remote tissue collector 58 such as the one depicted inFIGS. 21A-21C, the user can treat the proximal end of upper housing 52as a gun sight and align it with a target tissue.

When device 40 is used to cut tissue, outer cannula opening 49 must bealigned with the target tissue of interest to receive it for cutting.The entire device 40 can be rotated about the longitudinal axis ofhandpiece 42 to place outer cannula opening 49 at the desired location.However, this technique can be awkward and may reduce the surgeon'sdexterity. Thus, in an exemplary embodiment, device 40 includes aselectively rotatable outer cannula 44. As best seen in FIGS. 18-20 , arotation dial 60 is provided and is rotatably seated in a cavity definedby upper shell 54 and lower shell 56 of upper housing 52. Rotation dial60 is configured such that when it is rotated, it causes outer cannula44 to rotate about its longitudinal axis with respect to handpiece 42.Rotation dial 60 is preferably connected to an outer cannula connectorportion 88. In the embodiment of FIGS. 18-20 , outer cannula connectorportion 88 is a sleeve that is integrally formed with rotation dial 60and which is fixedly secured to outer cannula 44 such as by an adhesiveor other known connection means. In the exemplary embodiment of FIG. 20rotation dial 60 has an outer diameter that is greater than that ofsleeve 88. For ease of viewing, fluid supply sleeve 302 is not shown inFIG. 20 .

As mentioned previously, inner cannula 76 includes a hinge 80 to allowinner cannula cutting section 83 to pivot toward outer cannula opening49 when device 40 is in operation. In order to ensure the correctoperation of hinge 80, the circumferential alignment of hinge 80 andouter cannula opening 49 should be maintained. Thus, rotation dial 60 ispreferably connected to inner cannula 76 such that when rotation dial 60is rotated, both outer cannula 44 and inner cannula 76 rotate in a fixedangular orientation with respect to one another by an amount thatdirectly corresponds to the amount by which rotation dial 60 is rotated.Rotation dial 60 may be directly connected to inner cannula 76 or mayuse an intervening connecting device. However, rotation dial 60 shouldbe configured to allow inner cannula 76 to reciprocate with respect torotation dial 60. As best seen in FIG. 20 , rotation dial inner cannulaconnector 86 may be provided to connect rotation dial 60 to innercannula 76. Rotation dial inner cannula connector 86 comprises aproximal sleeve 87 disposed about inner cannula 76 and a distal,radially extending annular flange 90 with an outer diameter greater thanthat of the sleeve 87. Sleeve 87 and flange 90 may be in the shape ofcircular cylinders. Alternatively, and as shown in FIGS. 18-19 , sleeve87 and flange 90 may be in the shape of polygonal cylinders. Sleeve 87is slidably received within the annular cavity 130 at the distal end 126of the cannula transfer 74 and keyed to the inner surface of cannulatransfer 74 at annular cavity 130 such that sleeve 87 can reciprocatewith respect to cannula transfer 74 while causing cannula transfer 74 torotate with sleeve 87 when rotation dial 60 is rotated. When innercannula 76 is reciprocated, cannula transfer distal end 126 reciprocateswith respect to sleeve 87, thereby variably adjusting gap “G” definedwithin annular cavity 130 (FIG. 20 ). Alternatively, cannula transferdistal end 126 may be slidably received in an annular cavity formed insleeve 87 and may be keyed to the inner surface of the annular cavity sothat cannula transfer may reciprocate with respect to sleeve 87 whilestill rotating with sleeve 87 when dial 60 is rotates.

As best seen in FIG. 20 , rotation dial 60 includes a first annularcavity 61 that is sized to receive and engage flange 90 in a closefitting relationship. Rotation dial 60 may be press fit to flange 90. Inaddition, adhesive connections or mechanical connections may be used.Because rotation dial 60 is directly or indirectly connected to bothouter cannula 44 and inner cannula 76, both cannulae rotate in directcorrespondence to the rotation of rotation dial 60, thereby allowing theuser to adjust the orientation of outer cannula opening 49 and innercannula hinge 80 in a circumferential direction with respect tohandpiece 42. As a result, surgeons need not rotate the entire tissuecutting device 40 to obtain the desired angular orientation.

Rotation dial 60, outer cannula 44, and inner cannula 76 are preferablyconfigured for 360° rotation. In addition, tactile indicators arepreferably provided on rotation dial 60 to allow a user to reliablydetermine the extent to which dial 60 has been rotated from a givenstarting point. The tactile indication may comprise surface featuresdefined on or in the exterior surface of rotation dial 60. In oneexemplary embodiment, depicted in FIGS. 18-20 , a plurality of ridges122 is provided around the circumference of rotation dial 60 to providetactile indication. The ridges also act as grips and facilitate thesurgeon's ability to rotate the dial 60 without transferring unwantedmotion to the surgical site.

As mentioned previously, vacuum (sub-atmospheric pressure) is applied totissue collector 58 to aspirate severed tissue samples through innercannula 76 in the proximal direction. The application of vacuum to innercannula 76 via tissue collector vacuum hose fitting 59 will have apropensity to produce a vacuum at proximal end 45 of outer cannula 44 ifleakage occurs between inner cannula 76 and the components of upperhousing 52. The generation of a vacuum at outer cannula proximal end 45will in turn cause fluids and/or tissue samples at the distal end ofouter cannula 44 to flow into the annular clearance between innercannula 76 and outer cannula 44 that extends from its proximal end atouter cannula proximal end 45 to its distal end at inner cannula distalend 79. This fluid and/or tissue can result in blockage of the annularclearance and increased friction between the inner cannula 76 and outercannula 44, resulting in degraded performance. Accordingly, a seal 129is preferably provided to prevent air artifacts, fluid (water, saline,blood, etc.) flow, and tissue sample flow in the annular clearancebetween inner cannula 76 and outer cannula 44. The seal 129 ispreferably disposed adjacent the proximal end of the annular clearancebetween inner cannula 76 and outer cannula 44, i.e., proximally adjacentto outer cannula proximal end 45. As shown in FIG. 20 , seal 129 ispreferably annular and circumscribes inner cannula 76, extending fromthe outer surface of inner cannula 76 in a radially outward direction aswell as longitudinally along a portion of the length of inner cannula76.

In the embodiment of FIG. 20 , rotation dial 60 and sleeve 87 act as aseal housing and include a seal cavity 131 which is an annular cavitydisposed immediately adjacent to and distal of first annular cavity 61.Seal cavity 131 is sized to accept seal 129 therein. The seal 129 may bea conventional seal such as a solid, flexible and/or elastomeric o-ring.However, seal 129 is preferably amorphous and comprises a thixotropicmaterial that is a semi-solid. It is further preferred that seal 129fill the entirety of seal cavity 131 to ensure that cavity 131 issubstantially leak free. In the exemplary embodiment of FIG. 20 , sealcavity 131 has an outer diameter that is greater than the outer diameterof outer cannula 44. Moreover, the annular thickness of seal cavity 131is preferably greater than the annular clearance between outer cannula44 and inner cannula 76 to better ensure complete sealing of the annularclearance.

In one exemplary embodiment, seal 129 is a grease—such as the so-called“high vacuum greases”—that is formulated to withstand vacuum conditions.Suitable high vacuum greases include halogenated polymers. Thehalogenated polymers are preferably based on cyclic ether or unsaturatedhydrocarbon polymeric precursors. In one exemplary embodiment, aperfluroropolyether (PFPE) grease is used. Examples of such greasesinclude the FOMBLIN® family of greases supplied by Solvay Solexis, Inc.Other examples of such greases include polytetrafluroroethylene greases(“PTFE”) such as TEFLON greases supplied by DuPont. One suitable highvacuum grease is FOMBLIN® Y VAC3 grease, which is a PFPE grease with aPTFE thickener. The semi-solid seal 129 preferably has a kinematicviscosity at 20° C. of at least about 500 cSt, more preferably at leastabout 800 cSt, and even more preferably at least about 1200 cSt.Semi-solid seal 129 preferably has a kinematic viscosity at 20° C. of nogreater than about 2500 cSt, more preferably no greater than about 2000cSt, and even more preferably no greater than about 1700 cSt.

The use of a semi-solid seal 129 has several advantages. Because theseal is semi-solid, it will tend to absorb and dampen vibrationstransmitted from the reciprocation of the inner cannula, therebyreducing overall vibration of device 40, and in particular, thevibration transmitted to outer cannula 44. The dampening of suchvibrations is particularly beneficial because it reduces thetransmission of unwanted vibrations to outer cannula 44 which candisturb delicate neurosurgical procedures. Moreover, because it is not asolid seal, seal 129 will experience less heating and wear as it isfrictionally engaged by the reciprocating inner cannula 76. In certainembodiments, a portion of seal 129 will adhere to the outer surface ofinner cannula 76 as it reciprocates producing a zero slip velocitycondition at the inner cannula 76 outer surface which may further reducefrictional heating and degradation of seal 129. Because semi-solid seal129 produces less frictional resistance to the reciprocation of innercannula 76 as compared to conventional solid seals such as o-rings, italso decreases the required motor power consumption and can facilitatethe use of lower torque and lower cost motors, which in turn facilitatesmaking device 40 disposable.

In one configuration, device 40 is connected to a vacuum source andconfigured for variable aspiration, i.e., configured to supply variablelevels of vacuum to inner cannula lumen 78. As depicted in FIG. 21A, inone exemplary implementation, a tissue cutting system is provided whichcomprises tissue cutting device 40, a tissue collector 58, a controller132, a vacuum generator 153, a vacuum actuator 144, a controllable valve146, a vacuum line 151, and a fluid collection canister 192. Asmentioned previously, in FIG. 21A tissue collector 58 is locatedremotely from handpiece 42 and may be placed far enough from thehandpiece 42 to remain outside of the sterile field during a tissuecutting operation. As best seen in FIG. 21B, tissue collector 58 isgenerally the same as the tissue collector 58 depicted in FIGS. 4-5 .Vacuum line 151 a connects the distal end of tissue collector 58 toproximally projecting portion 95 of seal holder 94 on the proximal endof tissue cutting device upper housing 52. In one arrangement, theproximal end of vacuum line 151 a includes a hose fitting 59 b that isintegrally formed with a tissue collector coupler 296. Coupler 296 issimilar in structure to tissue collector connector 96 (FIGS. 4-5 ) andis a cylindrical structure with a hollow interior for receiving aportion of tissue collector 58. As best seen in FIG. 21B, tissuecollector 58 includes projections 202 and 204 which engage complementaryslots 298 and 200 in coupler 296 in the same manner that projections 102and 104 engage slots 98 and 100 in FIGS. 4-5 . At the proximal end oftissue collector 58, hose fitting 59 a engages vacuum line 151 b whichin turn is connected to fluid collection canister 192. Fluid collectioncanister 192 is connected to vacuum generator 153 via vacuum line 151 c.Vacuum generator 153 is connected to controllable valve 146 by way ofpressure line 147.

In yet another alternative arrangement, to provide nutrients for abiologically friendly, tissue efficacy prolonging environment to theresected tissue, referring to FIG. 21C, a preservation and tissuemaintaining adapter system 500 may be positioned between tissuecollector 58 and device 40. In one exemplary arrangement, preservationadapter system 500 is configured with a Y-shaped connector containing avalve element.

More specifically, preservation adapter system 500 includes a firstconnector element 502 (best seen in FIG. 21E) connected to a first endof a body portion 503 and a second connector element 504 connected to anopposite end of body portion 503. In one exemplary configuration, firstconnector element 502 may be configured to be received directly withinan open proximal end of a fitting 505 connected to vacuum line 151 a. Inthe exemplary configuration shown in FIG. 21C, an adapter element 506connects first connector element 502 to fitting 505. In the exemplaryconfiguration shown in FIG. 21C, adapter element 506 includes a firstend 507 that is sized to receive, or otherwise connect to, firstconnector element 502 in any suitable manner, including, but not limitedto, a threaded engagement. Adapter element 506 may be configured with anelongated body 508 that terminates in a second end 509. Second end 509is configured to be received within an open proximal end of fitting 505.In the exemplary configuration shown in FIG. 21C, body 508 tapers fromfirst end 507 to second end 509.

Second connector element 504 is configured to secure preservationadapter system 500 to tissue collector 58 via coupler 296. In oneexemplary configuration, second connector end 504 is configured to bereceived within, or otherwise connected to a fitting 510. Morespecifically, fitting 510 includes a first end 512 that receives secondconnector element 504, in any suitable manner, and a second end 514 thatis configured to connect to hose fitting 59 b.

A needless syringe port 511 intersects body portion 503. Port 511 may beconfigured with a valve element 516 (shown in phantom) in communicationwith an opening 518 to port 511. Port 511 (and valve element 516) allowfor introduction of solution to the tissue samples, while the tissuesamples being deposited into tissue collector 58.

More specifically, preservation adapter system 500 is configured topermit a controlled flow rate of a solution into the tissue collector58, and hence to permit the tissue samples to be bathed in thissolution. In one exemplary configuration, regulation of the quantity offluid flow that is delivered to the tissue within tissue collector 58may be defined by an internal diameter ID of a connector neck 520, thatis smaller than the flow channel defined by body portion 503. The fluidflow may also be controlled and/or restricted by an internal orifice(not shown), positioned within neck 520, whereby the orifice has adiameter that is smaller than the internal diameter ID of neck 520.Additionally, valve element 516, which may be provided as either fixedor adjustable valve, can be provided in-line with the internal diameterID of neck 520. Alternatively, a flow control valve (adjustable orfixed) may be provided in a supply line that serves as a connectionbetween port 518 and a source of preservation solution.

In operation, to assist in preservation of tissue samples, preservationadapter system 500 may be used to introduce a nutrient rich orpreservative solution into the artificial environment of tissuecollector 58 to keep the tissue samples properly hydrated and nourished.A source of suitable solution may be fluidly connected to port 518 viasuitable fitting and fluid supply such that vacuum may draw the solutionthrough valve 516 and internal diameter ID and into body 503, via vacuumline 151B. In another exemplary configuration, the solution introducedby preservation adapter system 500 may be chilled to further assist inpreserving tissue for future oncological use, but may be metered (byvalve 516 and/or internal diameter ID/orifice) to provide a specificflow rate for the solution being introduced.

Suitable fluids designed to maintain and/or preserve tissue samples forfurther use may be introduced via syringe. Alternatively, as suggestedabove, a solution may be automatically drawn into port 518 via thevacuum pressure supplied to tissue collector 58 via vacuum line 151B,thereby providing a consistent solution to the tissue samples.

As shown in FIG. 21C, vacuum line 151 b is attached to tissue collector58. In one exemplary arrangement, a connector element 522 having an openproximal end 524 is attached to vacuum line 151 b. Connector element 522may be fluidly connected to an inlet 523 (best seen in FIG. 21A) todeposit bodily fluids and excess solution within canister 192. However,to allow transport of excised tissue samples, while maintaining theaseptic environment in which the excised tissue samples are stored,connector element 522 is configured to be selectively released frominlet 523 and looped around and re-attached to hose fitting 59 b. Morespecifically, hose fitting 59 b is received within open proximal end524, thereby creating a closed environment system that may be easilytransported, without contacting the tissue samples. More specifically,this configuration provides an internally sterile/aseptic environmentthat is ingress proof from atmosphere conditions, while also beingcompliant with OSHA biohazard requirements such that tissue collector 58provides a fluid/leak proof chamber that is safe for the staff handlingtissue collector 58, as well as being compliant for easy transportation.

Returning to FIG. 21A, the outlet of tissue collection canister 192 ispreferably substantially liquid free and is connected to vacuumgenerator 153 via vacuum line 151 c. Thus, vacuum generator 153 is influid communication with tissue collector 58 and inner cannula lumen 78,thereby generating a vacuum at the proximal end 77 of inner cannula 76to aspirate severed tissue samples from inner cannula distal end 79 totissue collector 58. The level of vacuum generated by vacuum generatoris preferably variable and selectively controllable by a user. Maximumvacuum levels of at least about 0 in Hg. are preferred, and maximumvacuum levels of at least about 1 in Hg. are more preferred. Maximumvacuum levels of at least about 5 in Hg. are even more preferred, andmaximum vacuum levels of at least about 10 in Hg. are still morepreferred. Maximum vacuum levels of at least about 20 in. Hg. are yetmore preferred, and vacuum levels of at least about 29 in. Hg. are mostpreferred.

The controllable valve 146 and the vacuum generator 153 provide a meansfor continuously adjusting and controlling the level of vacuum appliedto tissue collector 58 and the proximal end of inner cannula lumen 78.Controllable valve 146 is supplied with a pressurized gas, preferablyair, or an inert gas such as nitrogen. In one exemplary embodiment, thepressure applied to controllable valve 146 is about 70 psi.

The system further includes an electrical controller 132 which receivesand provides signals to the various components to control or monitortheir operations. Controller 132 provides control signals to device 40via motor drive control line 142 to activate or deactivate motor 62. Anaspiration valve control line 150 extends from the controller 132 to thecontrollable valve 146 which provides pressure to the vacuum generator153. Signals to the controllable valve 146 through line 150 are used tocontrol the amount of vacuum applied to tissue collector 58.

Controller 132 also receives electrical signals from the variouscomponents of the system. For instance, a pressure transducer 148associated with the aspiration controllable valve 146, sends a signalalong line 152 to the controller 132. The signal is representative ofthe pressure supplied through controllable valve 146 to vacuum generator153. Thus, the transducer 148 provides immediate feedback to thecontroller which can in turn provide signals to aspiration controllablevalve 146.

The user can adjust the system operating parameters by using panelcontrols such as a console knob 138 and/or one or more depressiblecontrollers, such as a foot pedal 144. In one embodiment, foot pedal 144can be used to activate the motor 62 in device 40, causing the innercannula 76 to reciprocate within the outer cannula 44. In anotherembodiment, foot pedal 144 can be used to control the vacuum levelsupplied from vacuum generator 153 to tissue collector 58 and innercannula lumen 78. In yet another embodiment, foot pedal 144 can be usedboth to activate motor 62 and to control the vacuum level supplied fromvacuum generator 153 to tissue collector 58. In one arrangement, footpedal 144 is configured to variably increase the level of vacuum appliedto tissue collector 58 from a minimum level to a maximum level as footpedal 144 is depressed from a first position to a second position. Insuch an arrangement, the first position is one in which foot pedal 144is not depressed all or is only slightly depressed, and the secondposition is one in which foot pedal 144 is fully depressed. In anotherembodiment, knob 138 is used to set a preselected maximum vacuum levelapplied by vacuum generator 153. Thus, by depressing foot pedal 144 froma first fully open position to a second fully closed position, aplurality (preferably a continuum) of vacuum levels can be supplied totissue collector 58 with the maximum vacuum level being user adjustablevia knob 138.

In one exemplary embodiment, foot pedal 144 includes two switches (notshown) for providing variable vacuum and activating motor 62. In anotherexemplary embodiment, once foot pedal 144 is partially depressed from anopen or undepressed position, motor 62 is activated. In accordance withthe embodiment, continued depression of foot pedal 144 activates vacuumgenerator 153. Foot pedal 144 preferably provides continuous movementbetween a fully open and a fully depressed position which in turncorresponds to a plurality, and preferably a continuum, of vacuum levelsthat are supplied to inner cannula lumen 78. Once foot pedal 144 isfully depressed, the vacuum level supplied to inner cannula lumen 78corresponds to a previously selected maximum vacuum level.

In certain illustrative examples, the user will adjust the level ofvacuum to achieve a desired level of “traction” in the tissuesurrounding the tissue to be severed. As used herein, the term“traction” refers to the exertion of a pulling force on tissuesurrounding the target tissue to be severed. In some instances, tractionmay be visualizable by the surgeon with the use of a magnificationinstrument, such as a microscope or an endoscope. The level of vacuumwill also determine the amount of unsevered tissue that is drawn intoouter cannula opening 49, and therefore, the size of the severed tissuesnippets 112 (FIG. 14 ). Therefore, when fine shaving operations aredesired, the vacuum level will be a relatively lower level than ifdebulking (large scale tissue removal) is performed. Of course, thepre-selected maximum vacuum level will also affect the maximum size oftissue that is drawn into outer cannula opening 49, and therefore, willaffect the maximum size of severed tissue samples during any oneoperation. Also, the vacuum level may be adjusted based on theelasticity, fibrotic content, and hardness/softness of the tissue.

Console 134 may also include indicator lights 136, one of whichindicates the activation of cutting and one of which indicates theactivation of aspiration. Console 134 may further include an analogdisplay 140 with readouts for “aspiration” and “cutter.” The“aspiration” read out indicates the vacuum level supplied to tissuecollector 58 from vacuum generator 153. The “cutter” read out indicatesthe speed of reciprocation of inner cannula 76. In one embodiment, aspeed sensor is mounted in device 40 to determine the speed ofreciprocation of inner cannula 76 and the sensor is input to controller132.

As mentioned previously, when device 40 is used to perform a cuttingoperation, inner cannula 76 reciprocates within outer cannula opening 49to sever tissue received within outer cannula opening 49. When a cuttingoperation is complete, it may be preferred to have inner cannula 76 cometo rest at a position that is proximal of the proximal edge 53 of outercannula opening 49 to ensure that tissue is not trapped between innercannula distal end 79 and outer cannula cutting edge 51. However, incertain methods of use, tissue cutting device 40 may be used as anaspiration wand without cutting any tissue. In these embodiments, thestop position of the inner cannula distal end 79 within outer cannulaopening 49 determines the open area of the outer cannula 44, andtherefore, the aspiration levels that can be applied immediatelyadjacent outer cannula opening 49. Thus, in some preferred embodiments,the inner cannula stop position is user adjustable. Tissue cuttingdevice 40 may be used to aspirate a variety of fluids associated with aneurosurgical procedure, including without limitation blood, saline,cerebrospinal fluid, and lactated ringer's solution. In certainexamples, the inner cannula stop position is adjusted to provide adesired degree of aspiration, outer cannula 44 is positioned proximate atarget tissue, and vacuum is applied to manipulate the target tissue anddraw it into outer cannula opening 49. Outer cannula 44 is then moved toa desired location or orientation, thereby moving the target tissue tothe desired location or orientation. Once the target tissue has beensatisfactorily manipulated, a cutting operation is initiated. By usingdevice 40 in this manner, target tissues can be drawn away from areaswhere tissue cutting operations are undesirable, and the cutting can beperformed remotely from those areas.

In one exemplary system, an inner cannula position control is providedwhich controls the rest position of inner cannula 76 when motor 62 isdeactivated. Referring to FIG. 24 , cam rotational position indicators176 a and 176 b are mounted on the proximal end of cam 64. In anexemplary embodiment, cam rotational position indicators 176 a and 176 bare magnets having opposite poles. A position sensor 174 is mounted onthe inner surface of cam housing 69 and generates a signal indicative ofthe rotational position of indicators 176 a and 176 b relative toposition sensor 174. As mentioned previously, the rotation of cam 64correlates directly to the position of inner cannula 76 within outercannula 44. Thus, the rotation of cam 64 can be sensed to indirectlydetermine the position of inner cannula 76. Accordingly, indicators 176a/176 b and sensor 174 can be used to determine the position of innercannula 76 with respect to proximal edge 53 of outer cannula opening 49(FIGS. 10-12 ).

Referring to FIG. 22 , an embodiment of a system for controlling theoperation of tissue cutting device 40 is provided. The system includes amain control unit 158 (“MCU”), which (in the embodiment shown) isconfigured as a microprocessor-based system. In one implementation, MCU158 is incorporated in controller 132 (FIG. 21A) and is operable tocontrol the various operations of the tissue cutting device 40. Footswitch 144 is electrically connected to a number of inputs of MCU 158via an equal number, K, of signal paths 156, wherein K may be anyinteger. Panel controls, such as knob 138, are electrically connected toa number of inputs of MCU 158 via an equal number, J, of signal paths145, wherein J may be any integer.

Display unit 140 is electrically connected to a number of outputs of MCU158 via an equal number, Q, of signal paths 141, wherein Q may be anyinteger. In one exemplary implementation, depicted in FIG. 21A, displayunit 140 is provided on console 134.

As mentioned previously, tissue cutting device 40 includes motor 62coupled to the inner cannula 76 by an inner cannula drive assembly 63.The motor 62 is electrically connected to motor control unit 160 via anumber, M, of signal paths 161 wherein M may be any integer. The motorcontrol unit 160 is, in turn, connected to a number of outputs of MCU158 via an equal number, N, of signal paths 161. Cam rotational positionsensor 174 is electrically connected to a motor shaft position feedbackinput (SPF) of MCU 158 via signal path 162, and provides a motor stopidentification signal thereon as will be more fully describedhereinafter. The motor shaft stop identification signal provided bysensor 174 on signal path 162 preferably provides MCU 158 with a motorstop identification signal and may optionally provide a cutter speedsignal that is proportional to the motor speed for a geared system oridentical to the motor speed for a direct drive system.

Tissue cutting device 40 is further mechanically connected to a vacuumunit 168 (e.g., a combination of controllable valve 146 and vacuumgenerator 153 in FIG. 21A) via conduit 163 (not shown in FIG. 22 ),whereby the vacuum unit 168 provides a controllable vacuum level todevice 40 for aspirating tissue received in inner cannula lumen 78.Vacuum unit 168 is electrically connected to a vacuum control unit 166via a number, P, of signal paths 169 wherein P may be any integer. Thevacuum control unit 166 is, in turn, connected to a number of outputs ofMCU 158 via an equal number, L, of signal paths 167, wherein L may beany integer. A vacuum sensor 164, which may be a temperature compensatedsolid-state pressure sensor, may be positioned within the conduit 151and electrically connected to a vacuum feedback (VF) input of MCU 158via signal path 165. Alternatively, the vacuum sensor 164 may bedisposed within hand piece 42 or within the vacuum unit 168 itself.

In operation, the MCU 158 is responsive to a vacuum command signal,preferably provided by a corresponding control mechanism associated withcontrol panel 138, foot pedal 144, or an equivalent control mechanism,to provide one or more corresponding vacuum control signals to vacuumcontrol unit 166 along signal paths 167. The vacuum control unit 166, inturn, is responsive to the one or more vacuum control signals toactivate the vacuum unit 168 to thereby provide tissue cutting device 40with a desired level of vacuum. The actual vacuum level provided totissue cutting device 40 is sensed by vacuum sensor 164, which providesa corresponding vacuum feedback signal to the vacuum feedback input VFof MCU 158. The MCU 158 is then operable to compare the vacuum feedbacksignal with the vacuum command signal and correspondingly adjust the oneor more vacuum control signals to achieve the desired vacuum levelwithin tissue cutting device 40. Such closed-loop feedback techniquesare well known in the control systems art.

In one alternative embodiment, the MCU 158 can be replaced by individualmicroprocessors controlling the input and output for controlling theoperation of the motor 62 and the vacuum unit 168. In this alternativeembodiment, the motor control and vacuum control microprocessors can bePIC16CXX Series microcontrollers provided by Microchip, Inc. of ChandlerAriz. The motor control microcontrollers can receive input signals fromthe motor driver 172 (FIG. 23 ) and position sensor 174, as well as thefoot switch 144 and panel controls 138. Likewise, the vacuummicrocontroller can receive input signals from the vacuum sensor 164,the foot switch 144 and panel controls 138. Each microcontroller canprovide its own output to its driven component and have its own display,such as an LED display, indicative of its operational status. Moreover,the two units can communicate with each other to ensure clean cutting byproper timing of the cutting and aspiration functions.

Referring now to FIG. 23 , one exemplary embodiment of the motor controlunit 160 is shown in greater detail. The motor control unit 160 in oneembodiment includes a pulse width modulation (PWM) generator circuit 170having a motor speed input connected to one of the MCU outputs 161 ₁. Ifmotor speed control is provided, the output 161 ₁ can provide a variablevoltage signal indicative of a desired motor speed and based upon theposition of a throttle, foot pedal, or other actuator. In certainembodiments, an additional input is connected to another one of the MCUoutputs 161 ₂. The signal at this output 161 ₂ can be a motor slowdownsignal as described below. Alternatively, the output 161 ₂ canconstitute a braking signal used in connection with a current feedbackmotor controller. As a further alternative, the slowdown command may becommunicated via the motor speed command itself, rather than through aseparate signal 161 ₂. In this instance, the output 161 ₂ may not berequired.

In the illustrated embodiment, the PWM is disposed within the motorcontrol unit 160. Alternatively, the PWM can be integrated into the MCU158, or into the separate motor control microprocessor discussed above.In embodiments that include motor speed control, the motor speed inputreceives a motor speed signal from MCU 158 indicative of desiredoperational speed of the motor 62. The slowdown input can receive aspeed adjustment signal from the MCU 158 based on an actual motor speedsignal provided by a motor sensor associated with the motor 62.

A motor driver circuit 172 is electrically connected to PWM generatorcircuit 170 via signal path 173 and receives a PWM drive signaltherefrom, which is a pulse width modulated signal indicative of desiredmotor speed. The motor driver circuit 172 provides a motor drive signal(MD) to motor 62 via signal path 175. While the disclosed embodimentcontemplates digital control of the motor using the PWM generatorcircuit 170, alternative embodiments can utilize closed loop feedbackanalog circuits, particularly where slower cutting speeds arecontemplated.

The motor drive signal includes a motor stop input that is connected toanother one of the MCU outputs 161 ₁. In accordance with an aspect ofthe present disclosure, MCU 158 provides a motor stop signal on signalpath 161 ₃, based on a motor deactivation command provided by footswitch 144 or panel control 138 and also based on a motor stopidentification signal provided by sensor 174, to stop the inner cannula76 in a desired position, as will be more fully described hereinafter.In certain embodiments, only the motor stop signal is utilized tocommand the motor to stop at the predetermined position. In thesecertain embodiments, the motor slowdown signal on path 161 ₂ can beeliminated, or the input on path 161 ₂ can be used for other controlsignals to the motor control circuit.

As mentioned previously, when tissue cutting device 40 is deactivated,inner cannula 76 may come to rest partially disposed within outercannula opening 49. Referring to FIGS. 25-27 , three different stoppositions of inner cannula 76 are shown. For ease of viewing, fluidsupply sleeve 302 is not shown. FIG. 27 shows that inner cannula 76 canbe stopped in a position in which a portion of the tissue T is trappedbetween the outer cannula opening 49 and the inner cannula distal end79. Efforts at withdrawing outer cannula 44 from the surgical site mayaccordingly result in tearing of the tissue portion T′ away from thesurrounding tissue base T. Surgeons encountering such trapping wouldtypically be required to re-activate tissue cutting device 40 to releasethe tissue portion T′ from the surrounding tissue base T. To preventsuch tissue trapping from occurring, deactivation of the motor 62 iscontrolled in such a manner that the inner cannula distal end 79 ispositioned remotely from the outer cannula opening 49 when inner cannula76 stops reciprocating. However, in certain methods of use, device 40 isused as an aspiration wand. In those methods, the stop position of innercannula distal end 79 may be adjusted to different locations withinouter cannula opening 49 in order to adjust the level of aspirationsupplied to a region of the anatomy proximate outer cannula opening 49.For example, stop positions may be selected that limit the percent openarea of outer cannula opening 49 to 25%, 50%, or 75% of the total areaof opening 49.

Referring again to FIGS. 23 and 24 , controlled deactivation of themotor 62 will now be described in detail. When it is desired todeactivate tissue cutting device 40, a motor stop command is providedsuch as via foot switch 144 or a panel control 138. In one embodiment,MCU 158 is responsive to the motor stop command to provide a slowdownsignal to the PWM generator via signal path 161 ₂ which slows the actionof motor 62. Preferably, the slowdown signal corresponds to a predefinedsignal level operable to drive the motor 62 at a motor speed below amotor speed threshold level. Since motor 62 is a brushed DC motor, ithas a rotational resistance or resistive torque associated therewith asdescribed above. In addition, in some cases friction between the innercannula 76 and outer cannula 44 will increase the rotational resistance.Due to this combined rotational resistance, operation of the motor 62will cease very rapidly or nearly instantly if the motor drive signal onsignal path 142 is disabled while driving motor 62 below the motor speedthreshold. Accordingly, when device 40 is used to cut tissue, alignmentof position indicators 176 a or 176 b with sensor 174 preferablycorresponds to a position of the tissue cutting device 40 at which thereis no danger of trapping tissue between inner cannula distal end 79 andthe outer cannula opening 49, and sensor 174 is operable to produce themotor stop identification signal when so aligned with indicator 176 a or176 b.

In one embodiment, MCU 158 is operable to produce a motor stop signal onsignal path 161 ₃ when sensor 174 detects alignment of positionindicators 176 a or 176 b therewith after one passage thereby ofindicator 176 a or 176 b since producing the slowdown signal on signalpath 161 ₂. Allowing one passage of indicator 176 a or 176 b by sensor174 after issuing the slowdown signal ensures that the rotational speedof motor 62 is at or below the motor speed threshold when subsequentlyissuing the motor stop command, regardless of the position of indicator176 a or 176 b relative to sensor 174 when the slowdown command wasissued. After one passage of indicator 176 a or 176 b by sensor 174since issuing the slowdown signal, MCU 158 is responsive to the signalprovided by sensor 174 indicative of alignment of indicator 176 a or 176b therewith, to produce the motor stop signal on signal path 161 ₃. Themotor driver 172 is responsive to the motor stop signal to produce amotor disable signal on signal path 175. Due to the inherent rotationalresistance, motor 62 is responsive to the motor disable signal toimmediately cease operation thereof with indicator 176 a or 176 bsubstantially aligned with sensor 174, and with the inner cannula 76accordingly positioned so as not to trap tissue between inner cannuladistal end 79 and the outer cannula opening 44.

As mentioned above, in one exemplary embodiment, the inner cannula stopposition is user adjustable, such as by adjusting a panel control 138 onconsole 134. In accordance with the embodiment, it is contemplated thatthe stopped rotational position of cam 64, and therefore the innercannula distal end 79, may be instead aligned with a predetermineddifferential distance between the indicator 176 a/176 b and the sensor174. The braking characteristics of the inner cannula 76 and motor 62can be ascertained and the stopping distance determined so that thispredetermined differential distance can be calibrated accordingly.However, in a preferred embodiment, when inner cannula 76 comes to rest,the distal end 79 is located proximally of the outer cannula opening 44by a predetermined distance, as shown in FIG. 26 .

A method of using device 40 to perform a tissue cutting procedure willnow be described in the context of a neurosurgical procedure involvingthe cutting of a neurological target tissue. In one example, the targettissue is brain tissue, and in another example the target tissue isspinal tissue, for example, the tissue of an intervertebral disk. Incertain exemplary methods, the tissue specimen being cut is a tumor or alesion.

In accordance with the method, it is first determined whether thecutting operation will be a debulking operation, a fine shavingoperation, or a cutting operation that is somewhere in between adebulking and fine shaving operation. A surgical access path is thencreated to the tissue sample of interest. In one embodiment, thesurgical path is created and/or the target tissue is accessed using an“open” procedure in which the target tissue is open to the atmosphere(e.g., a full open craniotomy). In another embodiment, the surgical pathis created and/or the target tissue is accessed using a “closed”procedure in which the target tissue is sealed from the atmosphere.

At this point, the distal end 79 of inner cannula 76 is locatedproximally of outer cannula opening 49 due to the use of an innercannula stop position control of the type described previously. Themaximum vacuum level to be applied to device 40 is then set using panelcontrols 138. Generally, higher vacuum levels will be used for debulkingprocedures than for fine shaving procedures as higher vacuum levels willtend to draw relatively larger sections of tissue into outer cannulaopening 49. In one embodiment, the panel control 138 is a knob onconsole 134 that is rotated to set the desired maximum vacuum level.

In one arrangement, device 40 is configured to be gripped with a singlehand during a tissue cutting procedure. Thus, the surgeon will grasphandpiece 42 in the fingers of one hand and insert outer cannula 44 to alocation proximate the target tissue. Depending on the hand and thesurgeon's orientation with respect to the target tissue, the surgeon maythen rotate dial 60 to rotate outer cannula 44 about its ownlongitudinal axis and orient outer cannula opening 49 immediatelyadjacent the target tissue. The rotation of outer cannula 44 with dial60 causes inner cannula 76 to rotate such that a fixed rotational orangular relationship is maintained between inner cannula 76 and outercannula 44. Once the opening is in the desired orientation, the motor 62is activated, for example, by beginning to depress pedal 144 from itsfully undepressed (open) position to a second partially depressedposition which causes motor control unit 160 to send a signal to motor62 on signal path 142. Motor 62 may also be activated by a panel control138. The rotation of motor 62 causes cam 64 to rotate, resulting in thereciprocation of cam follower 68 and cam transfer 72. The reciprocationof cam transfer 72 causes cannula transfer 74 to reciprocate, therebyreciprocating inner cannula 76 within outer cannula lumen 110.

Once motor 62 is activated, vacuum is supplied to inner cannula lumen78. In one embodiment, as the pedal 144 is further depressed (beyond theposition at which motor 62 is activated), vacuum generator 153 isactivated. The surgeon then adjusts the degree of depression of the footpedal 144 to obtain the desired level of vacuum by visualizing themovement of the target tissue relative to the outer cannula opening 49.In certain embodiments, the surgeon controls the vacuum level to obtaina desired amount of traction in the tissue surrounding the targettissue. If the surgeon desires to apply the previously set maximumvacuum level, he or she depresses pedal 144 to its fully depressedposition.

If desired, the surgeon may depress and partially release the pedal 144a number of times to manipulate the target tissue in a satisfactorymanner. Vacuum controller 166 is manipulable to adjust the setpoint ofvacuum generator 153 which is manipulable to adjust the inner cannulavacuum level along a continuum of levels below the pre-selected maximumlevel. In one embodiment, the extent of depression of foot pedal 144dictates the vacuum set point supplied to vacuum control unit 166 onsignal path 167, and therefore, the amount of vacuum provided by vacuumunit 168. Vacuum sensor 164 measures the vacuum supplied to tissuecollector 58 and feeds a signal back to main control unit 158 on signalpath 165. The measured vacuum is then compared to the set point appliedto vacuum control unit 166 via foot pedal 144, and the signaltransmitted to vacuum generator 153 is then adjusted to move themeasured vacuum value towards the set point. To obtain a vacuum levelequal to the maximum pre-set level, pedal 144 is completely depressed.Maximum vacuum levels of at least about 0 in Hg. are preferred, andmaximum vacuum levels of at least about 1 in Hg. are more preferred.Maximum vacuum levels of at least about 5 in Hg. are even morepreferred, and maximum vacuum levels of at least about 10 in Hg. arestill more preferred. Maximum vacuum levels of at least about 20 in. Hg.are yet more preferred, and vacuum levels of at least about 29 in. Hg.are most preferred.

Due to the resistance of the tissue drawn into outer cannula opening 49,cutting section 83 pivots about hinge 80 and toward outer cannulaopening 49 as inner cannula 76 travels in the distal direction. Theinner cannula cutting section 83 continues to pivot as it travels in thedistal direction, eventually compressing tissue within outer cannulaopening 49 and severing it. The severed tissue forms a continuum oftissue snippets 112 (FIG. 14 ) within inner cannula lumen 78. Due to thevacuum applied to tissue collector 58, snippets 112 are aspiratedthrough inner cannula lumen 78 in the proximal direction. Theyeventually exit inner cannula lumen 78 at inner cannula proximal end 77and enter tissue collector 58 (or fluid collection canister 192 if nocollector 58 is provided). Any fluids that are aspirated exit tissuecollector 58 and are trapped in fluid collection canister 192. Thesurgeon preferably severs tissue at a cutting rate of at least about1,000 cuts/minute. Cutting rates of at least about 1,200 cuts/minute aremore preferred, and cutting rates of at least about 1,500 cuts/minuteare even more preferred. Cutting rates of less than about 2,500cuts/minute are preferred. Cutting rates of less than about 2,000 aremore preferred, and cutting rates of less than about 1,800 cuts/minuteare even more preferred.

The surgeon may move device 40 around the target tissue until thedesired degree of cutting has been completed. Motor 62 is thendeactivated, for example, by completely releasing pedal 144 so itreturns to its fully undepressed (open) position. If an inner cannulastop position control is provided, inner cannula 76 preferably comes torest proximally of outer cannula opening 49, as shown in FIG. 26 . Outercannula 44 is then removed from the surgical site. Tissue collector 58is then removed from upper housing 52 of handpiece 42, and the collectedtissue samples are either discarded or saved for subsequent analysis.Fluids collected in canister 192 are preferably discarded. If the remotetissue collector of FIG. 21A is used, tissue samples may be removed fromit without removing outer cannula 44 from the surgical site or otherwisedisturbing the surrounding tissue.

As mentioned previously, tissue cutting device 40 includes a fluidsupply sleeve 302 which is selectively disposable about outer cannula 44(i.e., the user can install or remove fluid supply sleeve 302 from outercannula 44) to provide fluid to a surgical site. As best seen in FIGS.28-31, fluid supply sleeve 302 includes an elongated channel section 304that comprises an outer cannula channel 314 and at least one fluidsupply channel through which fluids may pass. In the depictedembodiment, the at least one fluid supply channel is fluid supplychannel 312. When the fluid supply sleeve 302 is in an uninstalledcondition (e.g., FIG. 28 ), the fluid supply channel 312 may beseparated from the outer cannula channel 314 along all or a portion ofthe length of elongated channel section 304 by a barrier wall, membrane,etc. However, in the example of FIG. 30 , the outer cannula channel 314is in fluid communication with the fluid supply channel 312 along theentire length of elongated channel section 304 when the fluid supplysleeve 302 is in an uninstalled condition. As best seen in FIG. 30 ,when fluid supply sleeve 302 is in an installed condition, outer cannula44 occupies outer cannula channel 314 and effectively separates outercannula channel 314 from fluid supply channel 312.

Referring to FIG. 1 , hub 306 is connected to a fluid supply line 308,which is preferably a length of flexible, plastic tubing. Fluid supplyline 308 includes a fluid source connector 310 on its proximal end.Fluid source connector 310 may be any known type of connector suitablefor providing fluid flow. In the embodiment of FIG. 1 , fluid sourceconnector 310 is a male luer fitting.

Hub 306 may be connected to elongated channel section 304 in a varietyof ways. One example is depicted in FIG. 29 . As shown in the figure,proximal end 317 of elongated channel section 304 is connected to anddisposed in the interior of hub 306. Hub 306 preferably includes acomplementary channel (not separately shown) in which proximal end 317of elongated channel section 304 is interfitted. The connection betweenelongated channel section 304 and hub 306 may be made in a variety ofways, including with adhesives and mechanical fasteners. In addition,elongated channel section 304 may be integrally formed with hub 306 suchas by integrally molding elongated channel section 304 and hub 306 as asingle piece. In the embodiment of FIG. 29 , elongated channel section304 and hub 306 are separately formed and then connected with anadhesive.

Hub 306 is generally cylindrical in shape. Hub 306 also includes aproximal opening 322 and a distal opening 323. Outer cannula 344slidably projects through proximal end opening 322 and distal endopening 323. However, at distal hub end opening 323, outer cannula 44projects through elongated channel section 304 of fluid supply sleeve302. As shown in FIG. 1 , in one exemplary configuration, the distal end47 of outer cannula 44 projects through and away from the distal end 320of elongated channel section 340 when fluid supply sleeve 302 is in aninstalled condition on outer cannula 44. An interior channel (notseparately shown) is formed in the interior of hub 306 to retain outercannula 44. Hub 306 may also include exterior surface features whichenhance the user's ability to grip the hub such as when fluid supplysleeve 302 is being slid along outer cannula 44 to reposition fluidsupply sleeve 302 along the length of outer cannula 44. In one example,a plurality of longitudinally oriented grooves are spaced apart from oneanother around the circumference of hub 306 and are provided tofacilitate gripping. In another example, a plurality of protrudingaxially oriented ridges are provided and are spaced apart around thecircumference of hub 306.

Fluid supply port 316 is provided along the length of hub 306 and isconnected to fluid supply line 308. Fluid supply port 316 may comprisean opening in hub 306 and may also include a projecting connector orflange for securing fluid supply line 308 therein. Interior fluidchannel 318 is provided in hub 306 and is in fluid communication withfluid supply port 316 and with fluid supply channel 312 via openproximal end 319 in fluid supply channel 312. Elongated channel section304 includes a distal end opening 313 in the fluid supply channel 312through which fluid is discharged to the surgical site, typically at orproximate to a target tissue being resected.

Elongated channel section 304 is preferably rigid or semi-rigid and madeof a material that is suitable for use with sterilization techniques,such as ethylene oxide sterilization, Sterrad, autoclaving and gammaradiation sterilization. These include resins and metals. One type ofsuitable polymer material is heat shrinkable tubing. Additional suitableclasses of polymers for forming elongated channel section 304 includegamma-compatible polyimides and polyamides, such as Kapton® polyimidessupplied by DuPont, and Nomex polyamides supplied by DuPont. Polyesterand polyethylene heat shrink tubing are also suitable classes of polymermaterials. One exemplary class of heat shrink tubing is polyethyleneterephthalate (PET) heat shrink tubing supplied by Advanced Polymers,Inc. Suitable materials for forming hub 306 include stainless steel,aluminum, and polymeric materials such as silicone polymers, and naturalor synthetic rubbers.

As shown in FIG. 30 , outer cannula channel 314 is partially-cylindricaland defines a partially circular cross-section. Fluid supply channel 312may also be partially-cylindrical. However, in the example of FIG. 30 ,fluid supply channel 312 is generally in the shape of a partial ellipticcylinder (i.e., a cylinder with a partial elliptical cross-section).Inwardly directed ridges 324 and 326 define a transition between outercannula channel 314 and fluid supply channel 312 along the length offluid supply sleeve 302.

As mentioned previously, in one example, elongated channel section 304is formed from heat shrink tubing. In certain embodiments, the heatshrink tubing is provided as a cylindrical length of tubing and is thenmodified to provide a dual channel structure such as the one depicted inFIG. 30 . The dual channel structure may be provided by disposing thecylindrical heat shrink tubing around a mandrel having the cross-sectionof elongated channel section 304 which is depicted in FIG. 30 andapplying heat to shrink the cylindrical tubing and conform itscross-section to that of FIG. 30 .

In one preferred example, when fluid supply sleeve 302 is in aninstalled condition on outer cannula 44, outer cannula 44 may be rotatedwith respect to fluid supply sleeve 302. In one illustrative example,the surgeon may grip hub 306 with the fingers of one hand to restrainits rotational movement and rotate outer cannula rotation dial 60 withthe thumb and/or fingers of the other hand to adjust the circumferentialposition of outer cannula opening 49. While fluid supply sleeve 302 maybe configured to rotate with outer cannula 44, in many instances it ispreferable to maintain the circumferential orientation of fluid supplysleeve 302 in order to prevent fluid supply line 308 from twisting. Asshown in FIG. 1 , in one preferred orientation, fluid supply sleeve 302is circumferentially oriented such that fluid supply channel 312 isdisposed between the longitudinal axis Li of handpiece lower housing 50and outer cannula channel 314 in a direction that is substantiallyperpendicular to handpiece lower housing longitudinal axis Li. In oneexample, wherein fluid supply sleeve 302 is used to deliver a hemostaticagent, it is preferable to orient fluid supply channel 312 such that itis spaced apart from outer cannula opening 49 in a directionperpendicular to the lower housing longitudinal axis Li (see FIG. 31 )to prevent the aspiration of the hemostatic agent through outer cannulaopening 49. However, other fluid supply channel 312 orientations may beused depending on the procedure involved.

Fluid supply sleeve 302 may be connected to a fluid source via fluidsupply connector 310. The fluid source may be pressurized orunpressurized. Unpressurized fluids may be elevated to provide thenecessary hydrostatic head to deliver the fluids through fluid supplychannel 312.

A variety of different fluids may be delivered to a target tissue orproximate to the target tissue. In one example, irrigants such as salineare used to hydrate tissue at the surgical site, as well as to providehydration of the tissue while the excised tissue sample is beingaspirated. Further, in other exemplary arrangements, the fluid supplyoperatively connected to the fluid supply sleeve may include anutrient-rich solution configured to maintain the viability of thesamples excised by device 40. In yet another example, chilled fluid maybe provided through fluid supply sleeve 302 designed to preserve excisedtissue being aspirated through device 40. Saline elevated in temperaturemay also function as a hemostatic agent to initiate a “clotting cascade”which ultimately leads to the clotting of ruptured blood vessels intumors or other tissues at the surgical site. Other hemostatic agents,sealants, and/or tissue adhesives may also be delivered to a surgicalsite via fluid supply channel 312. Examples include liquid embolicsystems such as Neucrylate, a cyanoacrylate monomer derivative suppliedby Valor Medical. Neurcrylate is delivered as a liquid and forms aspongy, solid material upon contacting blood. Another example of asuitable hemostatic agent is supplied by Medafor, Inc. under the nameArista AH Absorbable Hemostat. Arista AH functions as a molecular filterby separating serum from cellular constituents. It absorbs water fromthe blood and forms a gel matrix that slows blood flow and serves toenhance clotting.

Fibrin sealants may also be delivered to a surgical site via fluidsupply channel 312. One suitable hemostatic matrix sealant is FloSeal®,a fibrin sealant comprising human thrombin which is supplied by BaxterHyland Immuno. Another suitable sealant is Tisseel, a VH Fibrin Sealantcomprising human thrombin, human fibrinogen, and bovine aprotinin.Certain sealants may comprise two or more fluid components that aremixed at or near the site of delivery. In such cases, the at least onefluid supply channel 312 preferably comprises two or more fluid supplychannels that contain the respective two or more fluid components whichare mixed at open distal end 313 of fluid supply channel 312. For fluidsthat are viscous and/or or gel-like in nature, a source of pressure suchas a pump is preferably provided to delivery them through fluid supplychannel 312 to the tissue.

Synthetic sealing agents may also be delivered via fluid supply channel312. One such example is CoSeal, a hydrogel comprising 2 polyethyleneglycol polymers supplied by Baxter. The 2 polymers are preferablydelivered via two separate fluid delivery channels and chemically bondto one another on mixing to form a mechanical barrier that slowsbleeding. Another suitable synthetic seal is Duraseal, which is suppliedby Confluent Surgical. Duraseal comprises a polyethylene glycol polymerester solution that is mixed at the point of delivery with a trilysineamine solution. Thus, fluid supply sleeve 302 is preferably providedwith two fluid delivery channels to facilitate mixing of the twosolutions at the point of delivery.

As mentioned above, in certain examples, it may be desirable to includetwo or more fluid supply channels in fluid supply sleeve 302. However,the two or more fluid supply channels need not be entirely separatealong the length of sleeve 302. Instead, they may combine to form asingle channel mixing zone at a defined distance from distal end opening313. The length of such a mixing zone is preferably selected to ensurethorough mixing without allowing the fluids to form a solidified mixtureprior to discharge from fluid supply sleeve 302.

Tissue adhesive glues are another category of fluids that may bedelivered via fluid supply sleeve 302. Suitable tissue adhesive gluesinclude those formed from formaldehyde or glutaraldehyde-based tissueadhesive glues. One suitable type of glutaraldehye based tissue adhesiveglue is BioGlue® a protein hydrogel comprising bovine serum albumin,glutaraldehyde, and water which is supplied by Cryolife, Inc. Dependingon the viscosity of the tissue adhesive glue, pressurized delivery maybe required.

In certain examples, elongated channel section 304 is formed with animageable material to facilitate the identification of its positionwithin the patient. In one example, elongated channel section 304includes an MRI-imageable material. In another example, elongatedchannel section 304 includes a positron emission tomography (PET)imageable material such as a radioactive isotope. Suitable isotopesinclude halogenated sugars such as [¹⁸F]fluorodeoxyglucose and isotopesof amino acids such as [¹¹C]methionine. In one example, PET imaging isperformed while fluid supply sleeve 302 is inserted in the patient tolocate the position of fluid supply sleeve 302 (and outer cannula 44)within the patient and relative to certain anatomical structures. Theradioactive isotope may be incorporated in the elongated channel section304 in a number of ways. In one example, the radioactive isotope isadded to a molten resin used to form elongated channel section 304 andsuspended within the solidified resin. In another example, elongatedchannel section 304 is formed with an inner and/or outer surface featuresuch as bores, holes, cavities, or channels and dipped into a solutioncontaining the radioactive isotope. The isotope then wicks into thesurface feature. The surface feature could also comprise a “rough”surface that defines a plurality of “valleys” in which the radioactivematerial would remain. In addition, the surface feature may compriseelectrostatic charges to attract and hold the radioactive materialthrough electrostatic forces.

Fluid supply sleeve 302 can be used to deliver fluids when tissuecutting device 40 is used in a tissue cutting mode or in an aspirationwand mode. In one example, a tissue removal system comprising tissuecutting device 40 with fluid supply sleeve 302 installed on the outercannula 44 is provided. A fluid source is provided and is connected tofluid source connector 310. A valve may be provided between the fluidsource and fluid source connector 310 to allow the surgeon toselectively deliver the fluid to fluid supply sleeve 302. Alternatively,a valve may be provided between fluid source connector 310 and hub 306.

The surgeon selectively positions fluid supply sleeve 302 at a desiredlocation along the length of outer cannula 44. In one example, thesurgeon grips hub 306 and advances or retracts fluid supply sleeve 302along outer cannula 44 to the desired location. The outer cannula 44 isthen inserted into the patient's body to a location proximate the targettissue. In one example, fluid is supplied from the fluid source throughfluid supply line 308, into hub 306, and through fluid supply channel312. The fluid then exits fluid supply sleeve 302 at fluid supplychannel open proximal end 319 and contacts the target tissue and/orsurrounding tissues proximate the target tissue. A vacuum level may thenbe supplied to inner cannula lumen 78 in the manner describedpreviously. Motor 62 may be activated as described previously to causeinner cannula 76 to reciprocate within outer cannula lumen 110 and severtissue received in outer cannula opening 49. Fluid may be supplied viafluid supply sleeve 302 before, during, and/or after reciprocation ofinner cannula 76 within outer cannula lumen 110. Severed tissue snippetsand/or fluids, including but not limited to the fluids supplied via thefluid supply sleeve 302, are then aspirated through inner cannula lumen78 and into tissue collector 58 as described previously.

In certain examples, tissue cutting device 40 may be used to cut tissueswith ruptured blood vessels which can cause significant bleeding. Onesuch example is a hemangioblastoma. In such cases, a hemostatic agent orsealant of the type described previously may be supplied during or afterthe tissue cutting procedure to minimize blood flow.

In another exemplary method, a tissue cutting system comprising tissuecutting device 40 and fluid supply sleeve 302 is provided, and thesystem is used in an aspiration mode. In accordance with the example,the surgeon selectively positions the fluid supply sleeve 302 along thelength of outer cannula 44 to occlude a portion of outer cannula opening49 as best seen in FIGS. 31 and 32 . The fluid supply sleeve 302 may beused to occlude a desired percent of the open area of outer cannulaopening 49 and therefore to selectively adjust the aspiration providedat outer cannula opening for a given vacuum level supplied to innercannula lumen 78. For example, fluid supply sleeve 302 positions may beselected that limit the percent open area of outer cannula opening 49 to25%, 50%, or 75% of the total area of opening 49. A vacuum level maythen be supplied to inner cannula lumen 78 and may draw surroundingtissues into the partially-occluded outer cannula opening 49. Inaddition, fluids may be aspirated through outer cannula opening 49,inner cannula lumen 78, tissue collector 58, and collected in fluidcollection canister 192 (FIG. 21A). With tissue drawn into outer cannulaopening 49, motor 62 may be activated to sever the received tissue andcollect it as described previously. Thus, fluid supply sleeve 302effectively allows the surgeon to manually adjust the degree ofaspiration at outer cannula opening 49, and correspondingly, the size ofthe tissue samples that are received in outer cannula opening 49 andsevered by inner cannula 76. Fluid may be supplied at or near the targettissue via fluid supply channel 312 before, during, and/or after tissueresection. However, fluid supply sleeve 302 may also be used to adjustthe degree of aspiration provided by tissue cutting device 40 withoutsupplying fluids.

It will be appreciated that the tissue cutting devices and methodsdescribed herein have broad applications. The foregoing embodiments werechosen and described in order to illustrate principles of the methodsand apparatuses as well as some practical applications. The precedingdescription enables others skilled in the art to utilize methods andapparatuses in various embodiments and with various modifications as aresuited to the particular use contemplated. In accordance with theprovisions of the patent statutes, the principles and modes of operationof this invention have been explained and illustrated in exemplaryembodiments.

It is intended that the scope of the present methods and apparatuses bedefined by the following claims. However, it must be understood thatthis invention may be practiced otherwise than is specifically explainedand illustrated without departing from its spirit or scope. It should beunderstood by those skilled in the art that various alternatives to theembodiments described herein may be employed in practicing the claimswithout departing from the spirit and scope as defined in the followingclaims. The scope of the invention should be determined, not withreference to the above description, but should instead be determinedwith reference to the appended claims, along with the full scope ofequivalents to which such claims are entitled. It is anticipated andintended that future developments will occur in the arts discussedherein, and that the disclosed systems and methods will be incorporatedinto such future examples. Furthermore, all terms used in the claims areintended to be given their broadest reasonable constructions and theirordinary meanings as understood by those skilled in the art unless anexplicit indication to the contrary is made herein. In particular, useof the singular articles such as “a,” “the,” “said,” etc. should be readto recite one or more of the indicated elements unless a claim recitesan explicit limitation to the contrary. It is intended that thefollowing claims define the scope of the invention and that the methodand apparatus within the scope of these claims and their equivalents becovered thereby. In sum, it should be understood that the invention iscapable of modification and variation and is limited only by thefollowing claims.

What is claimed is:
 1. A tissue sample retrieval and preservationsystem, comprising: a tissue removal device configured with an outercannula having an outer cannula opening that defines a cutting edge forsevering tissue, an inner cannula disposed in the outer cannula andreciprocable within the outer cannula, the inner cannula having acutting edge at the distal end that cooperates with the cutting edge ofthe outer cannula opening to sever tissue samples; a tissue collectoroperatively connected to the inner cannula and a vacuum generator,wherein the vacuum generator is configured to transport tissue samplessevered by the tissue removal device to the tissue collector through theinner cannula; and a temperature control sleeve disposed at leastpartially about the tissue collector to control the temperature of thetissue samples disposed within the tissue collector.